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

Radhika G. Sojitra,Urvi J. Chotaliya

doi:10.1186/s43094-021-00336-x

Radhika G. Sojitra, Urvi J. Chotaliya

Open Access

https://doi.org/10.1186/s43094-021-00336-x

Copy DOI

Abstract

BackgroundA specific, accurate, precise, robust, and cost-effective HPLC method was developed and validated for quantitative analysis of Fimasartan Potassium Trihydrate and Cilnidipine in fixed-dose combination. The isocratic elution was accomplished by Symmetry C18 column (150 mm × 4.6 mm, 5 µm) at 25 °C. Mobile phase composition is Methanol: Acetonitrile: Potassium Dihydrogen Phosphate buffer (pH 3) (60:05:35%v/v/v) at a flow rate of 1.0 mL/min, injection volume 20 µL with DAD detection at 240 nm.ResultFimasartan Potassium Trihydrate and Cilnidipine were eluted with retention time 2.65 min and 5.51 min respectively. This method was validated as per ICH guideline (Q2 R1). The calibration plots were over the concentration range of 15–90 μg/mL and 2.5–15 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine with correlation coefficient 0.9992 and 0.9989 respectively. Accuracy was obtained between 99.51–101.65% and 100.06–101.20% for Fimasartan Potassium Trihydrate and Cilnidipine respectively. LOD were found to be 0.97 μg/mL and 0.57 μg/mL and LOQ were found to be 2.95 μg/mL and 1.75 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine respectively.ConclusionThe results showed that the developed method is reliable for the routine analysis for simultaneous determination of Fimasartan Potassium Trihydrate and Cilnidipine.

Highlights

A specific, accurate, precise, robust, and cost-effective High-Performance Liquid Chromatography (HPLC) method was developed and validated for quantitative analysis of Fimasartan Potassium Trihydrate and Cilnidipine in fixed-dose combination
The results showed that the developed method is reliable for the routine analysis for simultaneous determination of Fimasartan Potassium Trihydrate and Cilnidipine
Optimized condition for method development Various mobile phase compositions, different columns, pH, flow rate were investigated and the best result was achieved on Symmetry C18 (150 mm × 4.6 mm, 5 μm) column with the mobile phase composition was Methanol: Potassium Dihydrogen Phosphate buffer: Acetonitrile (60:35:05% v/v/v) pH 3 adjusted with Ortho-phosphoric acid (OPA)

Summary

Introduction

A specific, accurate, precise, robust, and cost-effective HPLC method was developed and validated for quantitative analysis of Fimasartan Potassium Trihydrate and Cilnidipine in fixed-dose combination. Hypertension is defined as a sustained increase in blood pressure ≥ 140/90 mm Hg, a criterion where the risk of hypertension-related cardiovascular disease is high enough to merit medical attention [1]. It is the most common cardiovascular disease. A systolic pressure above 140 or a diastolic pressure above 90. Blood pressure is the lateral pressure exerted by blood on the wall of the blood. The reported solubility found in methanol and Acetonitrile [2]. It is used for the treatment of mild to moderate essential hypertension.

Results

Discussion

Conclusion