A NOVEL VALIDATED STABILITY INDICATING ANALYTICAL HPTLC METHOD FOR QUANTITATION OF HYDROCHLOROTHIAZIDE AND LISINOPRIL IN TABLET FORMULATION

Abstract

A new, simple and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of hydrochlorothiazide and lisinopril. Both the drugs were chromatographed on silica gel 60 F254 HPTLC plate using chloroform: methanol: ethyl acetate: acetic acid (7:2:1.0:0.2; V/V/V/V) as the mobile phase. Hydrochlorothiazide and lisinopril were quantified by densitometric analysis at 218 nm. The method was found to give compact bands for hydrochlorothiazide and lisinopril at Rf 0.43 and 0.75, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r2 0.9990 and 0.9992 in the concentration range 200–1200 ng band-1 and 250-1500 ng band-1, for hydrochlorothiazide and lisinopril, respectively. The method was validated as per the International Conference on Harmonization guidelines Q2(R1). The minimum detectable amounts were found to be 50.16 ng and 37.93 ng, whereas the limits of quantitation were found to be 150.48 and 113.92 ng for hydrochlorothiazide and lisinopril, respectively. Statistical analysis of the data showed that the method was precise, accurate, reproducible, selective and specific for the analysis of hydrochlorothiazide and lisinopril. The method was successfully employed for the routine quantitative estimation of hydrochlorothiazide and lisinopril in pharmaceutical tablet formulations.