Monday , 24 February 2020

Analytical Method Development and Validation for Candesartan and Amlodipine in combined Dosage Form by RP-HPLC

Rupani Srikanth1, P. Sowjanya2, Dr. G. Vijay Kumar3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
A new method was established for simultaneous estimation of Candesartan   and Amlodipine by RP-HPLC method. The chromatographic conditions were success fully developed for the separation of Candesartan and Amlodipine by using Symmetry C18 (4.0×250 mm) 5.0µm, flow rate was 1ml/min, mobile phase ratio was Methanol: Sodium acetate buffer (75: 35% v/v) pH 3 (pH was adjusted with orthophosphoricacid),detection wavelength was 250nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector 996, Empower-software version-2. The % purity of Candesartan and Amlodipine was found to be 101.27% and 99.97% respectively. The system suitability parameters for Candesartan and Amlodipine 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 n Candesartan and Amlodipine 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.
Keywords: Symmetry C18 column, Candesartan and Amlodipine, RP-HPLC

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