Tuesday , 18 May 2021

A New RP-HPLC Method Development and Validation for the Amlodipine and Perindopril in Bulk and Tablet Dosage Form

Y. Krishna Reddy*, A. Harikrishna, B. Tharun, B. Kishore, B. Saidhulu, B. Rajitha
Bomma Institute of Pharmacy, Khammam, Telangana, India

The chromatographic conditions were successfully developed for the separation of Amlodipine and Perindopril  by using Kromosil C 18  (250×4.6mm, 5µ) Column, The flow rate was 1ml/min, mobile phase ratio ortho phosphoric acid buffer: Methanol 65:35 were set (Buffer PH 2.45 adjusted with Triethylamine). The instrument used was Shimadzu UFLC-20 AD Chromatographic system (japan), SPD-M20A diode array, LC 20 software. The optimum wavelength for detection was 254 nm at which better detector response for both the drugs was obtained. The retention times for Amlodipine and Perindopril was found to be 2.589 ± 0.004 min and 3.711 ± 0.005 min, respectively. To ascertain its effectiveness, system suitability tests were carried out on freshly prepared stock solutions. The calibration was linear in concentration range of 20 to 60 μg/ ml and 10 to 30 μg/ml, with regression 0.9979 and 0.9999, Amlodipine and Perindopril respectively. The low values of % R.S.D indicate the method is precise and accurate. The mean recoveries were found above 99.3 % for both the drugs. Robustness of the proposed method was determined by varying various parameters, the %RSD reported was found to be less than 2 %. The proposed method was validated in accordance with ICH parameters and the applied for analysis of the same in marketed formulations.
Keywords: Amlodipine, Perindopril, HPLC

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