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Liquid Chromatographic Estimation of Dosulepin HCl and Methylcobalamin in Pharmaceutical Formulation.

Dhara B Desai, Dimal A Shah, Falgun A Mehta, Usmangani K Chhalotiya, and Kashyap K Bhatt

A sensitive, selective and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Dosulepin 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 KH2PO4and Methanol(50:40:10v/v, pH 6) was used as mobile phase. The Rtof Dosulepin and Methylcobalamin were observed to be 4and 2.1 minutes, respectively. Analysis was carried out in absorbance mode at 260 nm. The linear regression analysis data for the calibration plots showed a good linear relationship for Dosulepin and Methylcobalamin over a concentration range of 0.05-20 μg/ml and 0.1-20 μg/ml respectively with correlation co-efficient of 0.999forDosulepin and 0.9991 for methylcobalamin. The LOQ was found to be 0.05 and 0.1 μg/ml respectively for Dosulepin and Methylcobalamin. The method was validated as per ICH guideline and it was found to beaccurate, precise and robust. Marketed formulation was analyzed successfully.