Analytical method development and validation for simultaneous estimation of Fimasartan Potassium Trihydrate and Cilnidipine in synthetic mixture by HPLC for the treatment of hypertension stage-II

Abstract Background A specific, accurate, precise, robust, and cost-effective HPLC method was developed validated for quantitative analysis of Fimasartan Potassium Trihydrate Cilnidipine in fixed-dose combination. The isocratic elution accomplished by Symmetry C 18 column (150 mm × 4.6 mm, 5 µm) at 25 °C. Mobile phase composition is Methanol: Acetonitrile: Dihydrogen Phosphate buffer (pH 3) (60:05:35%v/v/v) a flow rate 1.0 mL/min, injection volume 20 µL with DAD detection 240 nm. Result were eluted retention time 2.65 min 5.51 respectively. This as per ICH guideline (Q2 R1). calibration plots over the concentration range 15–90 μg/mL 2.5–15 correlation coefficient 0.9992 0.9989 Accuracy obtained between 99.51–101.65% 100.06–101.20% LOD found to be 0.97 0.57 LOQ 2.95 1.75 Conclusion results showed that reliable routine simultaneous determination Cilnidipine.