Development and Validation of Stability Indicating RP-HPLC-PDA Method for Tenatoprazole and Its Application for Formulation Analysis and Dissolution Study

Abstract

A stability-indicating RP-HPLC-PDA method has been developed and subsequently validated for the determination of Acebrophylline in commercial capsules. The proposed HPLC method utilizes waters Cosmogel C18 column (150 mm x 4.6 mm, 5.0 μ particle size) and mobile phase consisting of methanol:acetate buffer (20:80 v/v) pH adjusted to 6 with glacial acetic acid at a flow rate of 0.85 mL/min and column was maintained at 50 0 C. Quantitation was achieved with UV detection at 274 nm based on peak area with linear calibration curves at concentration ranges 0.5-200 μg/mL for ACB (R 2 > 0.999). ACB and its drug products were exposed to acid, base and neutral hydrolysis, oxidation, heat and photolytic stress conditions. Under all these conditions, degraded products were well separated. The method was validated according to the ICH guidelines with respect to accuracy, precision, linearity, specificity, limits of detection, limits of quantitation and robustness. Method has been successively applied to assay of pharmaceutical formulation and dissolution study and no interference from the tablet excipients was observed. As the proposed method could effectively separate the drug from its degradation products, it can be employed as stability indicating method.