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Development and validation of UV Spectroscopic method for simultaneous estimation of Lafutidine and Rabeprazole sodium in bulk and Pharmaceutical dosage form

A simple, rapid, accurate, precise, sensitive and economical UVspectrophotometric method has been developed for simultaneous estimation of Lafutidine and Rabeprazole sodium from bulk and pharmaceutical formulation. The λmax of Lafutidine and Rabeprazole sodium in Methanol was found to be 272.6nm and 283.8 nm respectively.The method is based QAbsorption ratio method using two wavelengths, at 278.27nm(Isobestic point) and 283.8nm(λmax of Rabeprazole sodium). The parameters linearity, precision, accuracy, limit of detection and limit of quantitation, ruggedness were studied according to International Conference on Harmonization guidelines. The method follows linearity in the concentration range 5-30μg/ml and 10-60 μg/ml with correlation coefficient value R2 0.9998 and 0.9998 for Lafutidine and Rabeprazole sodium, respectively. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 99.19 % was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 50%, 100% and 150 %. The % recovery was found to be in the range 99.09%– 100.18%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. The above method was a cost-effective quality-control tool for routine analysis of Lafutidine and Rabeprazole sodium in bulk and in pharmaceutical dosage form

Author(s): Talaviya Piyushkumar M*, Mangukiya Krunal, Vachhani Jaydeep, Raja Jay V.

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