Stability-Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Fosinopril Sodium and Hydrochlorothiazide in Tablet Dosage Form.

Abstract

ABSTRACT:A simple, specific, accurate, reliable, and stability-indicating reverse-phase high-performance liquidchromatographic (RP-HPLC) technique was developed and validated for simultaneous quantitation ofFosinopril Sodium and Hydrochlorothiazide in bulk drugs as well as their pharmaceutical preparations.Chromatographic separation was carried out using Cosmosil C18 column (250 mm x 4.6 mm, 5μm) by isocraticelution of mobile phase consisting of Methanol: Water (60:40, v/v) at a flow rate of 0.8 ml/minute. Detectionwas done at wavelength of 218 nm having injection volume of 20μl and temperature of column maintained at25°C. Under the optimal conditions, Hydrochlorothiazide and Fosinopril Sodium eluted with retention times of4.13 min and 6.07 min, respectively, with reasonable peak symmetry and resolution.The proposed technique was validated following ICH Q2(R1) guidelines. Good specificity was shown for themethod without any interference from the blank and placebo components. Calibration curves were plotted in therange of 10-50 μg/mL for Fosinopril Sodium and 25-125 μg/mL for Hydrochlorothiazide. Excellent linearitywith correlation coefficient (R2) of 0.9995 and 0.9992 was observed for both analytes. Precision studiesexhibited %RSD values below 2.0%. For accuracy, mean recovery values ranged from 98%-102%.Forced degradation experiments were carried out using acidic, basic, oxidative, thermal, and photolytic stresses.The degradation of both drugs occurred under stress, and maximum degradation was noted under basic stressconditions. The degradation peaks of both drugs could be separated from the parent drug peaks, demonstratingthe stability-indicating ability of the technique.The method of reverse-phase high performance liquid chromatography (RP-HPLC) presented here isappropriate for the analysis of Fosinopril Sodium and Hydrochlorothiazide in quality control, assay, andstability studies.