Original Articles
Babikir H. El-Rasoul and Hana
Abstract
Amlodipine Besylate and hydrochlorothiazide combina tion is a long acting calcium channel blockers used as anti- hypertensive and for the treatment of angina. The c ombination is planned to be introduced very soon in the market in the Sudan. It is of vital importance that a vali dated and very precise analytical method should be established for the quantification of the components of this drug c ombination. The present study describes a reliable reverse phase high performance liquid chromatographic RP-HPLC met hod that has been developed and validated for the simultaneous estimation of amlodipine besylate and hydrochlorothiazide in pharmaceutical formulation. The combination were firstlyHPLC assayed and excellentl y resolved peaks were obtained via an RP – C 18 column. The mobile phase (mixture of Buffer pH 3.0: Acetonitril e: Methanol) was pumped at a flow rate of 1.0 mL mi n -1 in the ratio of (500: 300: 350, v/v) and the eluents were monitored by a uv-detector set up at 240 nm. The re tention time for amlodipine and hydrochlorothiazide was found to be 7.3 min and 3.1 min, respectively. Linearity w as ascertained via linear calibration curves for both drugs (R 2 = 0.9997 for amlopedine besylate and 0.9991 for hydrochlorothiazide) within the concentration range of 2.0–48 μg ml -1 for amlodipine besylate, and 10.0–120 μg ml - 1 for hydrochlorothiazide. The method was statistica lly validated and RSD was found to be less than 2% indicating high degree of accuracy and precision of the propos ed HPLC method. The percentage recoveries from the combined dosage form were between 99.79% to 102.84% for amlo depine and 98.16% to 100.58% for hydrochlorothiazide . The method is simple, rapid and of high degree of p recision and accuracy. The method can, confidently, be applied and utilized in pharmaceutical quality control labo ratories in routine analysis for determining amlodi pine besylate, and hydrochlorothiazide in bulk and in pharmaceutic al form.