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EN
A new, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) method has been established for simultaneous analysis of valsartan and hydrochlorothiazide in tablet formulations. Standard and sample solutions of valsartan and hydrochlorothiazide were applied to precoated silica gel G 60 F254 HPTLC plates and the plates were developed with chloroform–ethyl acetate–acetic acid, 5:5:0.2 (v/v), as mobile phase. UV detection was performed densitometrically at 248 nm. The retention factors of valsartan and hydrochlorothiazide were 0.27 and 0.56, respectively. The linear range was 800–5600 ng per spot for valsartan and 125–875 ng per spot for hydrochlorothiazide; the correlation coefficients, r, were 0.9998 and 0.9988, respectively. The method was validated in accordance with the requirements of ICH guidelines and was shown to be suitable for purpose. The method was successfully used for determination of the drugs in tablets. Tablet excipients did not interfere with the chromatography.
EN
A simple high-performance thin-layer chromatographic (HPTLC) method for separation and quantitative analysis of losartan potassium, atenolol, and hydrochlorothiazide in bulk and in pharmaceutical formulations has been established and validated. After extraction with methanol, sample and standard solutions were applied to prewashed silica gel plates and developed with toluene–methanol–triethylamine 6.5:4:0.5 (v/v) as mobile phase. Zones were scanned densitometrically at 274 nm. The RF values of losartan potassium, atenolol, and hydrochlorothiazide were 0.60, 0.43, and 0.29 respectively. Calibration plots were linear in the ranges 1000–5000 ng per band for losartan potassium and atenolol and 250–1250 ng per band for hydrochlorothiazide; the correlation coefficients, r, were 0.9994, 0.9993, and 0.9994, respectively. The suitability of this method for quantitative determination of these compounds was proved by validation in accordance with the requirements of pharmaceutical regulatory standards. The method was used for routine analysis of these drugs in bulk and in a formulation.
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