AJAC  Vol.2 No.2 , May 2011
Development and Validation of Stability Indicating RP-HPLC-PDA Method for Tenatoprazole and Its Application for Formulation Analysis and Dissolution Study
Abstract: In the present study, comprehensive stress testing of tenatoprazole was carried out according to ICH guide-line Q1A (R2). Tenatoprazole was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic, neutral and oxidative conditions. Mild degradation was observed in basic conditions. The drug is relatively stable in the solid-state. Successful separation of drug from degradation products formed under stress conditions was achieved on a Kromasil C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using methanol: THF: acetate buffer (68:12:20 v/v) pH adjusted to 6.0 with acetic acid as mobile phase, flow rate was 1.0 mL●min–1 and column was maintained at 45°C. Quantification and linearity was achieved at 307 nm over the concentration range of 0.5 - 160 μg●mL–1 for tenatoprazole. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.
Cite this paper: nullS. Dhaneshwar and V. Jagtap, "Development and Validation of Stability Indicating RP-HPLC-PDA Method for Tenatoprazole and Its Application for Formulation Analysis and Dissolution Study," American Journal of Analytical Chemistry, Vol. 2 No. 2, 2011, pp. 126-134. doi: 10.4236/ajac.2011.22014.

[1]   C. Scarpignato and I. Pelosini, “Review Article: The Opportunities and Benefits of Extended Acid Suppression Aliment,” Pharmacology and Therapeutics, Vol. 23, No. S2, 2006, pp. 23-34.

[2]   J. Guan, J. Yang, Y. Bi, S. Shi and F. Li, “Chiral Separation of Tenatoprazole Enantiomers Using High Performance Liquid Chromatography on Vacomycin-Bonded Chiral Stationary Phase,” Se Pu, Vol. 25, No. 5, 2007, pp. 732-734.

[3]   K. Uchiyama, D. Wakatsuki, B. Kakinoki, Y. Takeuchi, T. Araki and Y. Morinaka, “The Long-Lasting Effect of TU-199, a Novel H+, K+ -ATPase Inhibitor, on Gastric Acid Secretion in Dogs,” Journal of Pharmacy and Pharmacology, Vol. 51, No. 4, 1999, pp. 457-464. doi:10.1211/0022357991772510

[4]   A. H. Chun, K. Erdman, Y. Zhang, R. Achari and J. H. Cavanaugh, “Effect on Bioavailability of Admixing the Contents of Lansoprazole Capsules with Selected Soft F- oods,” Clinical Therapeutics, Vol. 22, No. 2, 2000, pp. 231-236. doi:10.1016/S0149-2918(00)88481-7

[5]   C. Larson, N. J. Cavuto, D. A. Flockhart and R. B. Weinberg, “Bioavailability and Efficacy of Omeprazole Given Orally and by Nasogastric Tube,” Digestive Diseases and Sciences, Vol. 41, No. 3, 1996, pp. 475-479. doi:10.1007/BF02282321

[6]   J. P. Galmiche, S. B. des Varannes, P. Ducrotte, S. Sacher-Huvelin, F. Vavasseur, A. Taccoen, P. Fiorentini and M. Homerin, “Tenatoprazole, a Novel Proton Pump Inhibitor with a Prolonged Plasma Half-Life: Effects on Intragastric pH and Comparison with Esomeprazole in Healthy Volunteers,” Aliment Pharmacology and Therapeutics, Vol. 19, No. 6, 2004, pp. 655-662. doi:10.1111/j.1365-2036.2004.01893.x

[7]   R. Nirogi, V. Kandikere, K. Mudigonda and G. Bhyrapuneni, “Quantification of Tenatoprazole in Rat Plasma by HPLC: Validation and Its Application to Pharmacokinetic Studies,” Biomedical Chromatography, Vol. 21, No. 12, 2007, pp. 1240-1244.doi:10.1002/bmc.875

[8]   P. Liu, B. Sun, X. Lu, F. Qin and F. Li, “HPLC Determination and Pharmacokinetic Study of Tenatoprazole in Dog Plasma after Oral Administration of Enteric-Coated Capsule,” Biomedical Chromatography, Vol. 21, No. 1, 2007, pp. 89-93. doi:10.1002/bmc.724

[9]   F. Domagala, H. Ficheux, G. Houin and J. Barre, “Pharmacokinetics of Tenatoprazole, a Newly Synthesized proton Pump Inhibitor, in Healthy Male Caucasian Vlunteers,” Arzneimittel Forschung, Vol. 56, 2006, pp. 33-39.

[10]   M. Mahadik, V. Bhusari, M. Kulkarni and S. Dhaneshwar, “LC-UV and LC-MS Evaluation of Stress Degradation Behavior of Tenatoprazole,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 50, No. 5, 2009, pp. 787-793. doi:10.1016/j.jpba.2009.06.026

[11]   ICH, “Q2 (R1) Validation of Analytical Procedures: Text and Methodology,” International Conference on Harmonization, Geneva, November 2005, pp. 1-13.

[12]   P. Lindberg, A. Brandstrom, B. Wallmark, H. Mattsson, L. Rikner and K. J. Hoffmann, “Omeprazole: The First Proton Pump Inhibitor,” Medical Care Research and Review, Vol. 10, No. 1, 1990, pp. 1-54.