ABSTRACT
A simple, rapid, precise, accurate and sensitive spectrophotometric method has been developed for the simultaneous estimation and validation of Nebivolol Hydrochloride (NEB) and Valsartan (VAL) in pure and combined tablet dosage forms. Pure drug samples of NEB and VAL were dissolved in 67 mM Phosphate buffer pH 6.8 with 0.5 % sodium dodecyl sulphate (SDS) and found to have absorbance maxima at 280 nm for NEB and 250 nm for VAL, respectively. The linearity lies between 10-70 μg/ml for NEB and 10-60 μg/ml for VAL in this method. The correlation coefficient (r2) was found to be 0.9965 for NEB and 0.9960 for VAL. The % recoveries obtained were 95.65 % – 109.85 % for NEB and 97.42 % – 101.43 % for VAL. The % RSD found 0.271 %-1.490 % for intraday and 0.334 %-1.917 % for interday for NEB and 0.188 %-0.944 % for intraday and 0.392 %-1.197 % for interday for VAL. The limit of detection and limit of quantitation for NEB were found to be 4.608 μg/ml and 13.965 μg/ml respectively and the limit of detection and limit of quantitation for VAL were found to be 4.348 μg/ml and 13.178 μg/ml respectively. Simultaneous calibration of both drugs in 67 mM Phosphate buffer pH 6.8 with 0.5 % SDS shows that λmax of one drug does not interfere on the λmax of other drug. Recovery study was performed to confirm the accuracy of the method. The results of analysis have been validated statistically by recovery studies as per International Conference on Harmonization guidelines. The method showed good reproducibility and recovery with % RSD <2. Hence, this proposed method was found to be rapid, specific, precise, accurate and can be successfully applied for the routine analysis of NEB and VAL in pure and combined tablet dosage form.
ABSTRACT
A simple, accurate and reproducible spectrophotometric methods have been developed for the simultaneous estimation of Telmisartan (TEL) and Amlodipine Besylate (AML) in combined tablet dosage forms. The method involves determination using the simultaneous equation method, the sampling wavelengths selected are ‘TLM’ = 297nm.and ‘AML’ =238nm., over the concentration ranges of 8-48µg/ml for ‘TEL’ and 1-6 µg/ml for ‘AML’ respectively. The method was validated for linearity, accuracy, precision, robustness and application for assay as per ICH guidelines. The proposed method is simple, economical, accurate and precise, and could be successfully employed in routine quality control for the simultaneous analysis of Telmisartan (TEL) and Amlodipine Besylate (AML).
ABSTRACT
Esomeprzole and naproxen are available in tablet dosage form in the ratio 1:25. Two simple, accurate, precise and economic methods; simultaneous equation method and multicomponent method have been described for the simultaneous estimation of esomeprzole and naproxen in tablet dosage form. Absorption maxima of esomeprzole and naproxen in distilled water were found to be 301.0 nm and 262.0 nm respectively. Beer’s law was obeyed in the concentration range 5-50 μg/ml for esomeprzole and 5-50 μg/ml for naproxen. The methods allow rapid analysis of binary pharmaceutical formulation with accuracy. Results of two methods were validated statistically and by recovery studies and were found to be satisfactory.