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Development and Validation of RP-HPLC Method for Determination of Dothiepin Hydrochloride in Bulk and Pharmaceutical Dosage Form


Author(s): Anita Ayre, Komal Ghude, Mayuri Nemade, Priya Mane, Paraag Gide

A RP-HPLC method has been developed and validated for the estimation of Dothiepin in bulk and pharmaceutical dosage form. The isocratic separation was achieved on a Shodex C18 column (250×4.6 mm, 5μm).The method was developed using mobile phase comprising of a mixture of 0.05 M phosphate buffer (pH adjusted to 2.6) and methanol (35:65, v/v) at a flow rate of 1.0 mL/min. The analyte was monitored with UV detector at a wavelength of 231 nm. The retention time of Dothiepin hydrochloride was found to be 6.78 min. The method was validated according to ICH guidelines for various parameters like accuracy, precision, specificity, linearity, robustness, LOD and LOQ. Linearity was observed in the concentration range of 0.5-5 μg/mL with a correlation coefficient of 0.999. The limit of detection and limit of quantification for Dothiepin hydrochloride were found to be 0.01µg/mL and 0.1µg/mL respectively. The proposed method is simple, accurate, precise and robust therefore can be used for routine analysis of Dothiepin hydrochloride in bulk drug and pharmaceutical formulation.

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