Sunday , 23 June 2024

Analytical Metthod Development and Vaidation for Felodipine and Simvastatin in combind dosage Form by RP-HPLC

Koduru Nikhitha*1, SK. Salma2
1PG Research Scholar, Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Nellore

2Assistant Professor, Department of Pharmaceutical Chemistry, Ratnam Institute of Pharmacy, Nellore, A.P.

A new method was established for simultaneous estimation of Felodipine and Simvastatin by RP-HPLC method. The chromatographic conditions were success fully developed for the separation of Felodipine and Simvastatin by using Thermosil C18 column (4.0×125mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate buffer pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength was 252nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.566 mins and 3.417mins. The % purity of felodipine and Simvastatin was found to be 101.27% and 99.97% respectively. The system suitability parameters for felodipine and Simvastatin such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Felodipine and Simvastatin was found in concentration range of 5µg-25µg and 50µg-250µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.86 and 0.82, % RSD for intermediate precision was 0.44 and 0.19 respectively. The precision study was precise, robust, and repeatable. LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively. Hence the suggested RP-HPLC

Keywords: Thermosil C18 column, Felodipine and Simvastatin, RP-HPLC

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