Bibliography

212

BIBLIOGRAPHY

Bibliography

213

Bibliography

Acharya, M. M. Pharmaceuticals stability testing and studies, an overview. The Eastern

Pharmacist 1999, 31-36.

Ahuja, S.; Alsante, K.M. Handbook of Isolation and Characterization of Impurities in

Pharmaceuticals. 1st ed. Volume 5, Academic Press, United Kingdom, 2003.

Ahuja, S.; Scypinski, S. Handbook of Modern Pharmaceutical Analysis. 1st ed. Volume

3, Academic Press, USA, 2001.

Alaa, S. A.; El-Sheikh, R.; Zahran, F.; Gouda, A.A. Spectrophotometric determination

of pipazethate HCl, dextromethorphan HBr and drotaverine hydrochloride in their

pharmaceutical preparations. Spectrochim. Acta A 2007, 67, 1088‐1093.

Alsante, K. M.; Ando, A.; Brown, R.; Ensing, J.; Hatajik, T. D.; Kong, W.; Tsuda, Y.

The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv.

Drug Deliver. Rev 2007, 59, 29-37.

Ante, M, K. Application of LC-MS methodology in the development of

pharmaceuticals. LC-GC Europe 2002, 1, 2-9.

Assie, M. B.; Charveron, M.; Palmier, C.; Puozzo, C.; Moret, C.; Briley, M. Effects of

prolonged administration of milnacipran, a new antidepressant, on receptors and monoamine

uptake in the brain of the rat. Neuropharmacol. 1992, 31,149-155.

Atsushi, S.; Takeshi, T.; Mami, N.; Hideki, K. ; Tatsuya, O.; Yoshiaki, I.; Miki, I.;

Koji, S.; Reiji, Y.; Yoichi, U.; Jun, N. Effects of repeated milnacipran administration on

brain serotonergic and noradrenergic functions in healthy volunteers. Psychopharmacol.

2006, 187, 526-527.

Ayad, M. M.; Youssef, N.F.; Abdellatif, H.E.; Soliman, S.M.; A comparative study on

various spectrometries with thin layer chromatography for simultaneous analysis of

drotaverine and nifuroxazide in capsules. Chemical and Pharma Bull. 2006, 54, 6807-6812.

Baltezor, M., Stability testing of drug products. In Grimm W, Paperback APV 16,

Wissenschaftliche Verlagsgfesellschaft, Stuttgart, 1985.

Baertschi, S.W. Analytical methodologies for discovering and profiling degradation-

related impurities. Trend. Anal. Chem. 2006, 25, (8), 758-767.

Bibliography

214

Baertschi, S.W. Pharmaceutical Stress Testing, Predicting Drug Degradation. Taylor

and Francis Group, FL, USA, 2005.

Bakshi, M.; Singh, S. Development of validated stability indicating assay methods-

critical review. J. Pharm. Biomed. Anal. 2002, 28 (6), 1011-1040.

Bari, S.B.; Impurity profile: significance in active pharmaceutical ingredient. Eurasian

J. Anal. Chem. 2007, 2(1), 32-53.

Bhuttani, H.; Singh, S.; Vir, S. K.; Asit, R.; Jindal, C. LC-MS study of stress

decomposition behavior of isoniazide and establishment of validated stability indicating

assays method. J. Pharm. Biomed. Anal. 2007, 43, 1213-1220.

Bjorkman, H.T.; Edlund, P.O.; Jacobsson, S.P. Tolterodine tartrate as model drug for

studying the sonic spray ionization in LC-MS. Anal. Chim. Acta 2002, 468, 263-274.

Blier, P.; Abbott, F.V. Putative mechanisms of action of antidepressant drugs in

affective and anxiety disorders and pain. J. Psychiatry Neurosci. 2001, 26, 37-43.

Bolaji, O. O.; Onyeji, C.O.; Ogungbamila, F. O.; Ogunbona, F. A.; Ogunlana, E. O.

HPLC method for the determination of drotaverine in human plasma and urine. J.

Chromatogr. Biomed. Appl. 1993, 622, 93-97.

Borgmann, H. M. S.; Parcianello, L.; Arend, M. Z.; Bajerski, L.; Cardoso, S. G.

Development and validation of a dissolution method with spectrophotometric analysis for

diacerhien capsules. Sci. Pharm. 2008, 76, 541-554.

Bolton, S.; Bon, C. Pharmaceutical Stastics: Practical and Clinical Applications. 4th

ed. Volume 135, New York Marcel and Dekker, 2004.

Borgmann, S. H.; Parcianello, L. M.; Arend, M. Z.; Cardoso, S.G. Direct

spectrophotometric determination of drotaverine in capsules. Pharmazie. 2007, 2, 483‐485.

Briley, M. Milnacipran a well‐tolerated specific serotonin and norepinephrin reuptake

inhibiting antidepressant. CNS Drug Rev. 1998, 4 (2), 137‐148.

Carstensen, J.T.; Rhodes, C.T. Drug Stability Principles and Practices. 3rd

ed. Marcel

Dekker, New York, 2002.

Chattopadhyay, J. Impurities in pharmaceuticals. The Eastern Pharmacist 1988, 3, 37-

42.

Bibliography

215

Chen, C.; Dyck, B.; Fleck, B. A.; Foster, A. C. Identification of 1S, 2R-milnacipran

analogs as potent norepinephrine and serotonin transporter inhibitors. Bioorg. Med. Chem.

2008, 18, 3328-3332.

Clark’s Analysis of Drugs and Poisons. Pharmaceutical Press, USA, 3rd

ed. Volume 2,

2004.

Costin, C. Recent progress in determination of volatile impurities in pharmaceuticals.

Trend. Anal. Chem. 2006, 25 (8), 768-777.

Daabees, H.G. Selective differential spectrophotometric methods for determination of

niclosamide and drotaverine. Anal. Lett. 2000, 33, 639-656.

David, C. The role of LC-MS in drug discovery. Recent Application in LC-MS, 2002,

11, 2-6.

Dias, C. L.; Bajerski, L.; Rossi, R. C.; Bergold, A. M.; Froehlich, P. E. Comparative

validation study to assay milnacipran hydrochloride in capsules by a stability-indicating LC

and a second order derivative UV spectroscopic methods. Pharm. Anal. Acta. 2010, 1, 1-5.

Dias, C. L.; Rossi, R. C.; Bajerski, L.; Froehlich, P. E. Dissolution method for

milnacipran hydrochloride capsules: development, validation, and study of changes in

dissolution rate after storage. Dissolution Technologies 2011, 47-53.

Duverneuil, C.; Grandmaison, G. L.; Mazancourt, P.; Alvarez, J. C. A high-

performance liquid chromatography method with photodiode-array UV detection for

therapeutic drug monitoring of the nontricyclic antidepressant drugs. Therapeutic Drug

Monitoring 2003, 25, 565-573.

Dwibhshyam, V. S. N.; Keerthy, P.; Ratanal, J. V.; Nagappa, A. N. Reverse-phase,

high performance liquid chromatographic method for the determination of tolterodine

tartrate in routine quality control sample. PDA J. Pharm. Sci. & Tech. 2009, 63 (3), 234-

239.

Ebru, U.; Cihat, S. Determination of milnacipran in human plasma using GC-MS

Chromatographia 2010, 72, 111-119.

El‐Wasseef, D.; El-Sherbiny, D.; Eid, M.; Belal, F. Spectrofluorometric determination

of drotaverine hydrochloride in pharmaceutical preparations. Anal. Lett. 2008, 41 (13),

2354‐2362.

Bibliography

216

El-Saharty, Y.S.; Metwally, F.H.; Refaat, M.; El-Khateeb, S.Z. Application of new

membrane selective electrodes for the determination of drotaverine hydrochloride in tablets

and plasma. J. Pharm. Biomed. Anal. 2006, 41,720-724.

Ermer, J. A quality concept for impurities during drug development-use of hyphenated

LC- MS technique. Pharm. Sci.Technol. 1998, (2), 76-82.

FDA, Guidance for Industry: Analytical Procedures and Methods Validation (Draft

guidance). Food and Drug Administration, Rockville, MD, 2000, 501-504.

FDA, Guidance for Industry INDs for Phase 2 and Phase 3 Studies, Chemistry,

Manufacturing and Controls Information, Federal Register 68, 2003, 27567-27568.

FDA, Submitting Documentation for The Stability of Human Drugs and Biologics.

CDER, 1987.

FDA, Guideline for The Photostability Testing of New Drug Substances and New Drug

Products. Federal Register 62, 1997, 27115-27122.

Giannellini, V.; Salvatore, F.; Bartolucci, G.; Coran, S. A.; Alberti, M. B. A validated

HPLC stability‐indicating method for the determination of drotaverine in bulk drug

substance. J. Pharm. Biomed. Anal. 2005, 39, 776-780.

Gorog, S. Drug safety, drug quality, drug analysis. J. Pharm. Biomed. Anal. 2008, 48,

247-253.

Gorog, S. The changing face of pharmaceutical analysis. Trend. Anal. Chem. 2007, 26

(1), 12-17.

Gorog, S.; Babjak, M.; Balogh, G.; Brlik, J.; Csehi, A.; Dravecz, F. Drug impurity

profiling strategies. Talanta 1977, 44, 1517-1526.

Hisham, E. A.; Magda, M.A.; Suzan, M. S.; Nadia, F.Y. Spectrophotometric and

spectrodensitometric determination of paracetamol and drotaverine HCl in combination.

Spectrochim. Acta Part A 2007, 66, 1147-1151.

Hosny, I.; Issa, Y.M.; Abu-Shawish, H. M. Improving the detection limits of

antispasmodic drugs electrodes by using modified membrane sensors with inner solid

contact. J. Pharm. Biomed. Anal. 2007, 44 (1), 8-15.

Indian Pharmacopoeia, Published by Ministry of Family and Health Welfare, Controller

of Publication, Delhi, 2010.

Bibliography

217

International Conference on Harmonization of Technical Requirements for

Registrations of Pharmaceuticals for Human Use. Impurities in New Drug Substances.

Geneva; Q3A (R2); 2006.

International Conference on Harmonization of Technical Requirements for

Registrations of Pharmaceuticals for Human Use. Impurities in New Drug Products.

Geneva; Q3B (R2); 2006.

International Conferences on Harmonization of Technical Requirements for

Registrations of Pharmaceuticals for Human Use. Impurities Guidelines for Residual

Solvents. Geneva; Q3C (R3); 2005.

International Conference on Harmonization of Technical Requirements for

Registrations of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text

and Methodology. Geneva; Q2 (R1); 2005.

International Conference on Harmonization of Technical Requirements for

Registrations of Pharmaceuticals for Human Use. Specifications: Test Procedures and

Acceptance Criteria for New Drug substances and New drug Products; Chemical Substances

Specification for Test Procedure Guidelines. Geneva; ICH Q 6A; 1999.

International Conference on Harmonization of Technical Requirements for

Registrations of Pharmaceuticals for Human Use. Stability Testing: Photostability Testing

of New Drug Substances and Drug Products. Geneva; Q1 B; 1996.

International Conference on Harmonization of Technical Requirements for

Registrations of Pharmaceuticals for Human Use. Stability Testing of New Drug substances

and Drug Products. Geneva; Q1 A (R2); 2003.

Jan, K.; Malgorzata, S. Densitometric determination of naproxen and naproxen methyl

ester its impurity in pharmaceutical preparations. J. Plan. Chromatogr. 2004, 17, 137-142.

John, K. R.; Richard, J. S. Use of liquid chromatography-nuclear magnetic resonance

spectroscopy for the identification of impurities in drug substances. J. Chromatogr. A. 1994,

677, 385-389.

John, C. L.; Directly coupled HPLC-NMR and HPLC-NMR-MS in pharmaceutical

research and development. J. Chromatogr. B. 2000, 748, 233-258.

Joachim E, The use of hyphenated LC-MS technique for characterization of impurity

Bibliography

218

profiles during drug development. J. Pharm. Biomed. Anal. 1998, 18, 707-714.

Jyotesh, J.; Riddhish, P.; Divyesh, V.; Renu, C.; Shailesh S. Dual wavelength

spectrophotometric method for simultaneous Estimation of drotaverine hydrochloride and

aceclofenac in their combined tablet dosage form. Int. J. Pharm. Pharm. Sci. 2010, 2, 76-79.

Katsumasa, M.; Yukihiko, S.; Morikuni, T.; Seiji, S. Brain region-specific effects of

short-term treatment with duloxetine, venlafaxine, milnacipran, and sertraline on

monoamine metabolism in rats. Neurochem. Res. 2009, 34,542-555.

Kazakevich, Y.; Lobrutto, R. HPLC for Pharmaceutical Scientist. John Wiley and

Sons, Inc., Hoboken, New Jersey, USA, 2007.

Kirti, S. T.; Rajesh, M. J.; Purushotam, K. S.; Mrinalini, C. D. A validated normal

phase HPLC method for simultaneous determination of drotaverine hydrochloride and

omeprazole in pharmaceutical Formulation. Asian Journal of Pharmaceutical and Clinical

Research 2010, 3, 20-24.

Klick, S. Toward a generic approach for stress testing of drug substances and drug

products. Pharm. Tech. 2009, 52, 48-66.

Kim, H.B. Handbook of Stability Testing in Pharmaceutical Development. Springer

Science Business Media, Spring Street, New York, USA, 2005.

Koji, S.; Yumiko, T.; Reiji, Y.; Masato, T. S.U.; Jun, N.; Nobuyuki, Y. Stimulation of

catecholamine synthesis via activation of p44/42 MAPK in cultured bovine adrenal

medullary cells by milnacipran. Arch. Pharmacol. 2007, 375, 65-72.

Krishna, S. R.; Rao, B. M.; Rao, N. S. A validated stability-indicating HPLC method

for the determination of related substances and assay of tolterodine tartarate. Rasayan J.

Chem. 2009, 2,144-150.

Labat, L.; Deveaux, M.; Dallet, P.; Dubost, J. P. Separation of new antidepressants and

their metabolites by micellar electrokinetic capillary chromatography. J. Chromatogr. B.

2002, 773, 17-23.

Lakshmi, M. V.; Rao, S. N.; Ravi Kumar, B. N. V. Development and validation of RP-

HPLC method for the estimation of milnacipran tablet dosage forms. International Journal

of Research in Pharmacy and Chemistry 2010, 1, 40-43.

Bibliography

219

Lalla, J.K.; Shah, M. U.; Jain, M.B.; Sharma, A. H. Modified HPLC method for

analysis of drotaverine in human plasma. J. Pharm. Biomed. Anal. 1993, 11, 385-388.

Lecoeur-Lorin, M.; Delepee, R.; Ribet, J. P.; Morin, P. Chiral analysis of milnacipran

by a nonchiral HPLC-circular dichroism: Improvement of the linearity of dichroic response

by temperature control. J. Sep. Sci. 2008, 31, 3009-3014.

Madhavi, A.; Reddy, G. S.; Suryanarayana, M. V.; Naidu, A. Development and

validation of a new analytical method for the determination of related components in

tolterodine tartarate using LC. Chromatographia 2008, 86, 399-407.

Mandava, V.; Basavasewara, R.; Bhumireddy, C. R.; Tumati, S. R.; Jamini, R. M.

Determination of tamsulosin hydrochloride 0.2% and tolterodine tartrate 0.2% combination

pellets by RP-HPLC method. Research Journal of Pharmaceutical, Biological and

Chemical Science 2010, 1,136-140.

March, J. Advanced Organic Chemistry, Reactions, Mechanisms and Structures. John

Wiley and Sons Wiley India (P), New Delhi, India, 2005.

Martindale, The Complete Drug Reference. Pharmaceutical Press, USA 35th

ed.

Volume 1, 2009.

McGovern, Timothy. David, J. K. Regulation of genotoxic and carcinogenic impurities

in drug substances and products. Trend. Anal. Chem. 2006, 25 (8), 790-795.

Metwally, F. H. Simultaneous determination of nifuroxazide and drotaverine

hydrochloride in pharmaceutical preparations by bivariate and multivariate spectral analysis.

Spectrochim. Acta A. 2008, 69, 343‐349.

Metwally, F.H.; Abdelkawy, M.; Naquib, I.A. Determination of nifuroxazide and

drotaverine hydrochloride in pharmaceutical preparations by three independent analytical

methods. J. AOAC Int. 2006, 89, 78‐87.

Metwally, F. H.; Fadia, H.; El-Saharty, Y.S.; Refaat, M.; El-Khateeb, S.Z. Application

of derivative, derivative ratio, and multivariate spectral analysis and thin‐layer

chromatography‐densitometry for determination of a ternary mixture containing drotaverine

hydrochloride, caffeine, and paracetamol. J. AOAC Int. 2007, 90, 391‐404.

Mezei, J.; Kuttel, S.; Szentmiklosi, P.; Marton, S.; Racz, I. A new method for high-

performance liquid chromatographic determination of drotaverine in plasma. J. Pharm. Sci.

Bibliography

220

2006, 73, 1489-1491.

Mishra, A.; Vasantharaju, S. G. Stability-indicating HPTLC method for analysis of

tolterodine in the bulk drug. J. Plan. Chromatogr. 2011, 24 (2), 150-153.

Moret, C.; Charveron, M.; Finberg, J.P.; Briley, M. Biochemical profile of midalcipran

(F2207), 1‐phenyl‐1‐diethyleaminocarbonyl‐2‐ aminoethyle‐cyclopropane (Z)

hydrochloride, a potential fourth generation antidepressant drug. Neuropharmacol. 1985, 24,

(12), 1211‐1219.

Mubarakunnisa, M.; Rani, P.A.; Harika, S. Development and validation of RP-HPLC

method for estimation of milnacipran HCl in pharmaceutical formulations. Int. J. Pharm.

2012, 2(4), 801-805.

Munson, W. H. Pharmaceutical Analysis Modern Methods. Part B, Marcel Dekker,

New York, 2001.

Muth, J. D. Basic Statistics and Pharmaceutical Statistical Applications. 2nd

ed.

Chapman and Hall-CRC, 1999.

Nanda, R. K.; Gaikwad, J.; Prakash, A. Estimation of tamsulosin and tolterodine in its

pharmaceutical dosage form by spectrophotometric method. Int. J. PharmTech Res. 2009, 1

(3), 420-423.

Niessen, W. M.A. Liquid Chromatography-Mass Spectrometry. Chromatographic

science series, Taylor & Francis Group, FL, USA, 2006.

Oliver, M. D. Impurity profiling of pholcodeine by liquid chromatography electrospray

ionization mass spectrometry (LC-ESI-MS). J. Pharm. Pharmacol. 2002, 54, 87-96.

Ovalles, J. F. Determination of piracitam and its impurities by TLC. J. Pharm.

Biomed.Anal. 2000, 23, 757-761.

Palmor, L.; Andersson, L.; Andersson, T.; Stenberg, U. Tolterodine and the 5-

hydroxymethyl metabolite in plasma, serum, and urine using gas chromatography-mass

spectrometry. J. Pharm. Biomed. Anal. 1997, 16, 155-165.

Panigrahi, D.; Sharma, R. Development and validation of an RP-HPLC method for

simultaneous analysis of drotaverine and omeprazole in a tablet dosage form. Acta

Chromatographica 2008, 20, 439‐450.

Patel, K. N. Introduction to hyphenated techniques and their applications in pharmacy.

Bibliography

221

Pharm. Methods 2010, 1(1), 2-13.

Parejiya, P.B.; Shelat, P.K.; Patel, R.C.; Barot, B.S.; Shukla, A.K. Development and

validation of UV spectrophotopmetric method for determeination of milnacipran in bulk and

pharmaceutical dosage form. Eurasian J. Anal. Chem. 2011, 6(1), 53-58.

Patti, A.; Pedotti, S.; Sanfilippo, C. Chiral HPLC analysis of milnacipran and its

FMOC-derivative on cellulose-based stationary phases. Chirality 2008, 23, 63-68.

Pavia, D. L.; Lampman, G. M.; Kriz, G.S. Introduction to Spectroscopy. 3rd

ed.

Thomson Learning Inc, USA, 2001.

Piyush, S.; Singh, S. Study of forced degradation behavior of enalapril maleate by LC

and LC-MS and development of a validated stability-indicating assay method. J. Pharm.

Biomed. Anal. 2008, 46, 113-120.

Prasad, P. D.; Bari, S. B.; Bhoir, S. High performance liquid chromatographic

estimation of drotaverine hydrochloride and mefenamic acid in human plasma. Iranian

Journal of Pharmaceutical Research 2009, 8 (3), 209-215.

Praveen, P. S.; Valluri, J.; Baratam, A. Validated RP-HPLC method for analysis of

milnacipran in bulk and in formulations. International Research Journal of Pharmacy

2010, 1, 138-144.

Puech, A.; Montgomery, S.; Prost, J.; Solles, A.; Briley, M. Milnacipran, a new

serotonin and noradrenaline reuptake inhibitor: an overview of its antidepressant activity

and clinical tolerability. Int. Clin.Psychopharmacol. 1997, 12, 99-108.

Puozzo, C.; Filaquier, C.; Zorza, G. Determination of milnacipran, a serotonin and

noradrenaline reuptake inhibitor, in human plasma using liquid chromatography with

spectrofluorometric detection. J. Chromatogr. B. 2004, 806, 221-228.

Puozzo, C.; Panconi, E.; Deprez, D. Pharmacology and pharmacokinetics of

milnacipran. Int. Clin. Psychopharmacol. 2002, 17, 25S-35S.

Ravindra, K. N., Jagdish, G., Anand, P. Simultaneous RP-HPLC estimation of

tamsulosin and tolterodine in its pharmaceutical dosage form. Journal of Pharmacy

Research 2009, 2, 1786-1788.

Bibliography

222

Ravindra, K. N.; Jagdish, G.; Anand, P. Simultaneous spectroscopic estimation of

tolterodine in pharmaceutical dosage form. Research J. Pharm. and Tech. 2009, 2, 312-314.

Ravindrakumar,Y.; Ramulu,G.; Vevakanand, V.V.; Vaidyanathan, G.; Keesari, S.;

Kishore, K.; Satyanarayana, M.R.; Suryanarayana, M.V. A validated chiral HPLC method

for the enantiomeric separation of tolterodine tartrate. J. Pharm. Biomed. Anal. 2004, 35,

1279-1285.

Rao, M.S.; sivaramakrishna, V.; Vardhan, S.V.M., Ramachandran, D. A validated RP-

HPLC method for estimation of milnacipran in tablet dosage forms. Int. J. ChemTech Res.

2011, 3(3), 1501-1505.

Rao, M.V.B.; Reddy, B.C.K.; Srinivas, T. R.; Rao, G. V. Drug release method by

HPLC for tamsulosin hydrochloride 0.2% and tolterodine tartrate 0.2% combination pellets.

International Journal of Chemical Engineering Research 2009, 1 (2), 155-159.

Rao, R. N.; Nagaraju, V. An overview of the recent trends in development of HPLC

methods for determination of impurities in drugs. J. Pharm. Biomed. Anal. 2003, 33, 335-

377.

Roy, J. Pharmaceutical impurities- A mini-review, AAPS Pharm. Sci. Tech. 2002, 3 (2),

1-8.

Sethi, P.D. HPTLC Quantitative Analysis of Pharmaceutical Formulations. CBS

publishers and distributors, New Delhi, India, 1996.

Shaq, B. M.; Vinita, K. P.; Manual, B.; Hair, C. K.; Usher, G. R. New aurum coupling

reaction for visible spectrophotometric determination of tolterodine tartrate in

pharmaceutical preparations. International Journal of Chemical and Analytical Science

2010, 1,165-167.

Shinozuka, T.; Terada, M.; Tanaka, E. Solid-phase extraction and analysis of 20

antidepressant drugs in human plasma by LC/MS with SSI method. Forensic. Sci. Int. 2006,

162, 108-112.

Shuto, S.; Takada, H.; Mochizuki, D.; Tsujita, R.; Hase, Y.; Ono, S.; Shibuya, N.;

Matsuda, A. (±)‐ (Z)‐2‐(aminomethyl)‐1‐ phenylcyclopropanecarboxamibe derivatives as a

new prototype of NMDA receptor antagonists. J. Med. Chem. 1995, 38, 2964‐2968.

Bibliography

223

Silverstein, R.M.; Bassler, G.C.; Morrill, T.C. Spectrometric Identification of Organic

Compounds. John Wiley and Sons, Inc, New York, 1991.

Singh, S.; Bakshi, M. Guidance on conduct of stress tests to determine inherent stability

of drugs. Pharm. Tech. On-line 2000, 24, 1-14.

Singh, S.; Bakshi, M.; Ojha, T. Validated specific HPLC methods for determination of

prazosin,terazosin and doxazosin in presence of degradation products formed under ICH-

recommneded sress conditions. J. Pharm. Biomed. Anal. 2004, 34 19-26.

Shetty, S. K. Development and validation of tolterodine by RP-HPLC method in bulk

drug and pharmaceutical dosage forms. Int. J. PharmTech Res. 2011, 3 (2), 1083-1087.

Smith, R. J.; Webb, M. L. Analysis of Drug Impurities, 1st ed. Blackwell Publishing

Ltd, United Kingdom, 2007.

Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical

Products. World Health Organization, WHO Technical Report Series, No. 953, 2009.

Stability Testing of New Drugs Substances and Products. Proceedings of the

International Conference on Harmonization (ICH), IFPMA, Geneva, Switzerland, 2002.

Stahl, E. Thin-Layer Chromatography A Laboratory Handbook. Springer international

edition, berline, Heidelberg, 2005.

Suganthi, A.; Thengungal, K.R. Stability indicating HPLC method for simultaneous

determination of drotaverine and aceclofenac. Int. J. Pharm. Pharm. Sci. 2011, 3, 245-250.

Swart, R.; Koivisto, P.; Markides, K.E. Capillary solid-phase extraction-tandem mass

spectrometry for fast quantification of free concentrations of tolterodine tartrate and two

metabolites in ultrafiltered plasma samples. J. Chromatogr. B. 1999, 736, 247-253.

Syal, P. K.; Sahoo, M.; Ingale, K. D.; Ingale, S. S.; Choudhari, V. P.; Kuchekar, B. S.

Development and validation of a RP-HPLC-PDA method for simultaneous estimation of

drotaverine and etoricoxib in tablet and its application for dissolution studies. Der. Pharma

Chemica.2010, 2, 93-102.

Tatsuo, S.; Masaru, T.; Einosuke, T. Solid-phase extraction and analysis of 20

antidepressant drugs in human plasma by LC/MS with SSI method. Forensic Sci. Int. 2005,

162, (3) 108-112.

Tettey, J. N. A. HPTLC and HPLC Determination of isometamidium in presence of its

Bibliography

224

manufacturing and degradation impurities. J. Pharm. Biomed. Anal. 1998, 17, 713-718.

The Merck Index. An Encyclopedia of Chemicals, Drugs, and Biologicals. 14th

ed.

Merck research Laboratories, Whitehouse Station, NJ; Merck & Co., Inc USA, 2006.

Tondepu, N.; Sait, S.S.; Surendranath, K.V.; Kaja, R.K.; Kumar, S. A stability

indicating U-HPLC method for milnaciparan in bulks and pharmaceutical dosage forms.

American journal of Analytical Chemistry 2012, 3, 40-49.

Tournel, G.; Houdret, N.; Hedouin, V.; Deveaux, M.; Gosset, D.; Lhermitte, M. High-

performance liquid chromatographic method to screen and quantitate seven selective

serotonin reuptake inhibitors in human serum. J. Chromatogr. B. 2001, 761, 147-158.

United States Pharmacopoeia, United States Pharmacopeia Convention, Pending

monograph for public comment. 2010.

USP, United States Pharmacopoeia, 31st ed. NF 26. United States Pharmacopeia

Convention, Asian edition, Rockville, 2010, p.1225.

Vaishnavi, S. N.; Nemeroff, C.B.; Plott, S. J.; Rao, S. G.; Kranzler, J. Milnacipran: a

comparative analysis of human monoamine uptake and transporter binding affinity. Bio.

Psych.2004, 55, 320-322.

Vikram, G. M.; Dipali, D. T.; Kunal, D. I.; Amruta, S. B.; Vishnu, P. C.; Bhanudas, S.

K. Spectrophotometric determination of drotaverine and aceclofenac in combined tablet

dosage form By ratio derivative spectroscopy and area under curve (AUC)

spectrophotometric methods. International Journal of Pharmaceutical Science Review and

Research 2010, 3, 111-114.

Vinay, S.; Zahid, Z.; Mazhar, F. Stability-indicating HPLC determination of tolterodine

tartrate in pharmaceutical dosage form. Indian J. Chem. Technol. 2006, 13, 242-246.

Vishnu, C.; Kunal, I.; Madhusmita, S.; Pratima, Syal.; Snehal, I.; Santosh, S.; Abhijit,

S.; Bhanudas, K. Development and validation of a RP-HPLC-PDA method for simultaneous

estimation of drotaverine and aceclofenac in a combined dosage form. Int. J. Res. Pharm.

Sci. 2010, 1, 253-258.

Vivek, S.R.; Santosh, V. G.; Upasana, P.P.; Mahima, S. Simultaneous determination of

drotaverine hydrochloride and aceclofenac in tablet dosage form by spectrophotometry.

Eurasian J. Anal. Chem. 2009, 4, 184‐190.

Bibliography

225

Watson, J.T.; Sparkman, O.D. Introduction to Mass Spectrometry. John Wiley and

Sons, Ltd. Sussex, England, 2007.

Wellings, D. A. A Practical Handbook of Preperative HPLC. Elsevier publication,

Aamsterdam, Netherlands, 2006.

www.usp.org/pdf/EN/pendingStandards/tolterodineTartrate.pdf; Retrieved on 14th

August 2010.

Xia, Development of an enantiospecific HPLC method for the determination of (S)-

enantiomer impurities in (R) tolterodine tartrate. Pharmazie. 2007, 62 (3), 170-173.

Yadav, M.; Upadhyay, V.; Chauvan, V.; Solanki, G.; Jani, A.; Baxi, G. A.; Singhal, P.;

Shrivastav, S. P. Separation and determination of tolterodine and its active metabolite, 5-

hydroxymethyl tolterodine in human plasma by LC-MS-MS. Chromatographia 2010, 72

(3), 255-264.

Zayed, S.I.M.; Issa, Y. M. Catholic adsorptive stripping voltammetry of drotaverine

hydrochloride and its determination in tablets and human urine by differential pulse

voltammetry. Bioelectrochem.2009, 75, 9-12.

Zhang, B.; Zhang, Z.; Tian, Y.; Xu, F. High performance liquid chromatography-

Electrospray ionization mass spectrometric determination of tolterodine tartrate in human

plasma. J. Chromatogr. B. 2005, 824 (1-2), 92-98.

Ziyatdinova, G.K.; Samigullin, A. I.; Budnikov, G. K. Voltammetric determination of

papaverine and drotaverine. J. Anal. Chem. 2007, 62, 773-776.

Zsuzsanna, T.; Olivier, F.; Peter, A. Drotaverine interacts with the L-type Ca2+ channel

in pregnant rat uterine membranes. Eur. J. Pharmacol. 2002, 449, 55-60.