Development and validation of HPTLC method for simultaneous estimation of Valsartan and Hydrochlorothiazide in tablet dosage form

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DOI: 10.4103/2231-4040.197331

A simple and sensitive high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of valsartan and hydrochlorothiazide in combined dosage forms. The chromatographic development was carried out on aluminum plates precoated with silica gel 60 F254 using a mixture of Chloroform: Methanol: Formic acid (4:1:0.05, v/v/v) as mobile phase. The detection was carried out densitometrically using UV detector at 264 nm in absorbance mode. This system was found to give separation for valsartan with Rf 0.76 and hydrochlorothiazide with Rf 0.44. The method was validated according to ICH Q2 (R1) guidelines. The calibration curve was found to be linear between 1000 – 7000 ng/spot and 200 – 1000 ng/spot for valsartan and hydrochlorothiazide, respectively with significantly high value of correlation coefficient (r2 = 0.99). The limits of detection and quantitation were found to be 391 and 1185.1 ng/spot, respectively for valsartan and 57.37 and 173.8 ng/spot, respectively for hydrochlorothiazide. The percentage assay was found to be 99.25 and 101.2 while accuracy was accessed by percentage recovery and found to be 100.64 and 99.84 for valsartan and hydrochlorothiazide, respectively. The proposed method was found to be accurate, precise, reproducible, and specific and can be applicable for the simultaneous determination of valsartan and hydrochlorothiazide in tablet dosage form.

Keywords: Valsartan, Hydrochlorothiazide, High performance thin layer chromatography, Validation, Specificity, Accuracy