DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING HPLC METHOD FOR THE SIMULTANEOUS ANALYSIS OF ISOPROPAMIDE AND TRIFLUOPERAZINE IN FIXED-DOSE COMBINATION TABLETS

摘要

A simple, precise isocratic stability indicating RP‐HPLC method was developed for the determination of isopropamide and trifluoperazine in pure and its pharmaceutical formulations. In the developed method, methanol, acetonitrile and water in the ratio of 40:30:30 (v/v) as mobile phase and Waters C-18 (250mm x 4.6mm, 5μm) column as stationary phase were used. The flow rate and detection wavelength were 0.9mL/min and 240 nm respectively. The method was validated as per ICH guidelines for specificity, linearity and range, precision, accuracy, robustness, solution stability, limit of quantification and limit of detection. The stability-indicating capability was established by forced degradation experiments. The results of all the validation parameters were well within their acceptance limits and also the degradation products formed during different stress conditions in stability studies were separated from both drugs and also from individual degradation products. This validated method was applied for the simultaneous estimation of isopropamide and trifluoperazine in commercially available formulation sample.