development and validation of stability indicating rp-hplc-pda method for tenatoprazole and its application for formulation analysis and dissolution study稳定的发展和验证表明rp-hplc-pda tenatoprazole方法及其应用配方分析和分解研究.pdfVIP

American Journal of Analytical Chemistry, 2011, 2, 126-134 doi:10.4236/ajac.2011.22014 Published Online May 20 11 (http://www.SciRP.org/journal/ajac) Development and Validation of Stability Indicating RP-HPLC-PDA Method for Tenatoprazole and Its Application for Formulation Analysis and Dissolution Study Sunil R. Dhaneshwar, Vaijanath N. Jagtap Department of Pharmaceutical Chemistry , Bharati Vidyapeeth University, Poona College of Pharmacy, Maharashtra , India E-mail: sunil.dhaneshwar@, vnjagtap@yahoo.co.in Received November 17, 2010; revised January 21, 2011; accepted January 24, 2011 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 ad- justed 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. Keywords: Stability Indicating RP-HPLC-PDA, Method Validation, Column Liquid Chromatography 1. Introduction