ABSTRACT
A simple, specific, rapid, precise and robust HPLC method has been developed for the quantitation of valsartan in tablet dosage form on a C18 column (250 x 4.6 mm) using a mobile phase consisting of ammonium dihydrogen phosphate buffer : methanol (33.5:66.5) adjusted to pH 3 with formic acid at a flow rate of 1.0 ml/min and detection at 265 nm. The retention time of valsartan was found to be at 11.9 min. The validation of above method was also done. Percentage label claim of the tablet formulations were found to be 100.8%. So the proposed method provides a faster and cost effective quality control tool for routine analysis of valsartan from formulations.
ABSTRACT
A new, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) method has been established for quantitative analysis of valsartan in tablet formulations. Standard and sample solutions of valsartan were applied to precoated silica gel G 60 F254 HPTLC plates and the plates were developed with chloroform: acetonitrile: toluene: glacial acetic acid, in the ratio 1:8:1:0.1 (v/v) (v/v), as mobile phase. UV detection was performed at 254 nm. The retention factors of valsartan was 0.65. The calibration plot for Valsartan standard was linear with r =0.9999, slope = 5.328 and intercept=356.9. The limit of detection and limit of quantitation of Valsartan were found to be 5and 16 ng per spot respectively. The percentage recovery was found to be 99.37% for Valsartan. The method showed good repeatability and recovery with relative standard deviation less than 2. Method was validated in accordance with the requirements of ICH guidelines and was shown to be suitable for purpose. The method is selective and specific can be used for determination of the routine analysis of valsartan in tablets. Tablet excipients did not interfere with the chromatography.