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Liquid Chromatographic Estimation of Epalrestat and Methylcobalamin in Pharmaceutical Formulation.

Krima R Patel, Dimal A Shah, Falgun A Mehta, Usmangani K.Chhalotiya, Kashyap K Bhatt

A sensitive, selective and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Epalrestat and Methylcobalamin both as a bulk drug and in formulation. The method employed Luna C18 column (250 x 4.6 mm id, 5 μm particle size) as the stationary phase while acetonitrile: 0.02 M KH2PO4 buffer (90:10 v/v, pH 6.5) was used as mobile phase. The Rt of Epalrestat and Methylcobalamin were observed to be 5.2 and 2.1 minutes, respectively. Analysis was carried out in absorbance mode at 254 nm. The linear regression analysis data for the calibration plots showed a good linear relationship for Epalrestat and Methylcobalamin over a concentration range of 1- 40 μg/ml and 0.2-10 μg/ml respectively with correlation co-efficient of 0.9995 for epalrestat and 0.9991 for methylcobalamin. The LOQ was found to be 0.2 μg/ml for epalrestat and 0.8 μg/ml for methylcobalamin. The method was validated as per ICH guideline and it was found to be accurate, precise and robust. Marketed formulation was analyzed successfully.