Stability Indicating RP-HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine from Their Combination Drug Products

The study describes development and subsequent validation of a stability indicating reverse-phase HPLC method for the simultaneous estimation of atorvastatin (ATV), and amlodipine (AML) from their combination drug product. The proposed RP-HPLC method utilizes a Lichrospher 100 C18, 5 microm, 250 mm x 4.0 mm i.d. column, at ambient temperature, optimum mobile phase consisted of acetonitrile and 50 mM potassium dihydrogen phosphate buffer (60 : 40, v/v), apparent pH adjusted to 3+/-0.1 with 10% phosphoric acid solution, effluent flow rate monitored at 1.0 ml/min, and UV detection at 254 nm. ATV, AML, and their combination drug product were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by proposed method. The method was applied for the in vitro dissolution of marketed combination drug products. The described method was linear over the range of 1-90 microg/ml and 1-80 microg/ml for ATV and AML, respectively. The mean recoveries were 99.76 and 98.12% for ATV and AML, respectively. The intermediate precision data obtained under different experimental setup, the calculated value of coefficient of variation (CV, %) was found to be less than critical value. The limit of detection for ATV and AML were found to be 0.4 and 0.6 mug/ml, respectively and the limit of quantification was 1.0 microg/ml for both drugs. The average percentage drug release was found to be more than 70% within 30 min for both drugs. Chromatographic peak purity data of ATV and AML indicated no co-eluting peaks with the main peaks of drugs which demonstrated the specificity of assay method for their estimation in presence of degradation products. The proposed method can be useful in the quality control and in vitro dissolution of combination drug products.