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S. B. Wankhede ¹, K. C. Raka ¹, S. B. Wadkar ¹, S. S. Chitlange ¹

Affiliations
1 Department of Pharmaceutical Chemistry, Padmashri Dr. D. Y. Patil Institute of Pharmaceutical Sciences band Research, Sant Tukaram Nagar, Pimpri, Pune-411018, IN

Abstract

The present work describes a stability-indicating HPTLC method for simultaneous analysis of Amlodipine besilate (AMLO), Losartan Potassium (LOS) and Hydrochlorothiazide (HCTZ) in bulk and pharmaceutical dosage form. Aluminium plate precoated with silica gel 60 F₂₅₄ was used as stationary phase. The separation was carried out using chloroform: ethyl acetate: methanol: ammonia (4: 4: 2:0.2 v/v/v/v) as mobile phase. The densitometric scanning was carried out at 232 nm. The linearity was obtained in the range 100-800 ng per band for amlodipine besilate (Correlation coefficient: 0.9954), 400-2400 ng per band for hydrochlorothiazide (Correlation coefficient: 0.9952) and 1000-8000 ng per band for losartan potassium (Correlation coefficient: 0.9947). The method was validated as per ICH guidelines. The combined dose tablet formulation was subjected to forced degradation by acid, alkali, oxidation, dry heat and exposure to ultraviolet radiations at 254 nm. The degradation products were well resolved from the pure drug with significantly different R_f values.

Keywords

Amlodipine Besilate (AMLO), Losartan Potassium (LOS), Hydrochlorothiazide (HCTZ), HPTLC, Validation, Stability Studies.

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S. B. Wankhede ¹, A. Prakash ¹, S. S. Chitlange ¹

Affiliations
1 Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Sant Tukaram Nagar, Pimpri, Pune-18, IN

Abstract

Two accurate, precise, rapid and economical methods were developed for the estimation of Ofloxacin and Satranidazole in tablet dosage form. First method is first order derivative spectroscopy, wavelengths selected for quantitation were 259.0 nm for Ofloxacin (zero cross for Satranidazole) and 227.0 nm for Satranidazole (zero cross for Ofloxacin). Second method is area under curve method; area under curve in the range of 292.5-282.5 nm (for Ofloxacin) and 325.0-315.0 nm (for Satranidazole) were selected for the analysis. In both the methods linearity for detector response was observed in the concentration range of 5-40 μg/ml for Ofloxacin and Satranidazole, both. The proposed methods were successfully applied for the simultaneous determination of both drugs in commercial tablet preparation. The results of the analysis have been validated statistically and by recovery studies.

Keywords

Ofloxacin, Satranidazole, Derivative Spectroscopy, Area Under Curve Method.

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