Hplc Method Development and Validation for the Simultaneous Estimation of Pitavastatin and Telmisartan

Method validation of both the compounds was done on the basis of ICH guidelines. Validation by HPLC method the wavelength was selected at the isobestic point at which the two drugs can be detected using UV detectors. The selected wavelength was 250nm. Optimized liquid chromatographic condition was obtained by performing many trials for the selection of mobile phase and column, for the separation of Pitavastatin & Telmisartan. The method development was conducted with C18, 250 × 4.6 mm, 5µm particle size, Phenomenex with the flow rate of 1.0mL/min. the optimized mobile phase conditions were Acetonitrile and 10mM Ammonium acetate buffer containing 0.1% formic acid in the ratio of 65:35 v/v. Data of Simultaneous shows retention time for Pitavastatin 5.408 & Telmisartan was 7.183. The method found to be linear, accurate, rugged and robust for validated parameters. The linearity range was determined by external standard calibration method in the concentration range of 10μg/ml to 60μg/ml. The amount of recovery was calculated as 98% – 101% and it was observed that all the values are within the limits. Further the precision of the method was confirmed by the repeatable analysis of sample. The results were found to be precise due to low values of the %RSD. It indicated that the method has good precision. Limit of quantification for Pitavastatin & for Telmisartan 1.554μg/ml and 4.709μg/ml respectively. Similarly limit of detection for Pitavastatin & for Telmisartan 0.647μg/ml and 1.959μg/ml respectively. In the robustness study %RSD obtained for change of flow rate and wavelength and ruggedness for change of analyst was found to be below 2, which was within the acceptance criteria. So, simple, sensitive, accurate, precise RP- HPLC methods were developed and validated for the simultaneous estimation of Pitavastatin & Telmisartan.