Development of novel validated RP-HPLC method for the simultaneous determination of perindropil and amlodipine with possible degradants in fixed dose pharmaceutical formulation

A new simple, sensitive, rapid, precise, suitable and cost-effective reversed-phase stability indicating HPLC method was developed and validated in compliance with ICH Q2R1 guidelines for the simultaneous estimation of the Perindropil and Amlodipine in the fixed dose pharmaceutical formulation. The effective chromatographic separation was achieved with 0.1% TEA buffer of PH 4.5 and Acetonitrile in the ratio of 65:35 as mobile phase, at a flow rate of 1.0ml/min on HPLC system containing UV- detector with Xbridge column (150x4.6 mm; 5μ). The detection was carried out at 237nm. The retention time was found to be 3.089 and 4.201 min for Perindropil and Amlodipine respectively. The optimized method gave the good resolution and suitable retention time. The linear range was 8-40μg/ml for Perindropil (r² = 0.998) and 10-50μg/ml for Amlodipine (r² = 0.998). Percentage recoveries were found to be 99.58% and 100.4% for Perindropil and Amlodipine respectively. The method was statistically validated and all the analytical validation parameters were found to be within the limits indicating the validity of the method. %RSD was found to be less than 2.0 indicating high degree of accuracy and precision. Both the drugs were subjected to acid and base hydrolysis, oxidation, heat and photolysis to apply the stress. The degradation studies indicated that the drugs were susceptible under various degradation conditions thus indicating that the degradation of drugs had occurred. Thus the proposed method can be applied for the simultaneous estimation of the Perindropil and Amlodipine in the marketed formulation.