Aim: A simple, sensitive, accurate and precise RP-HPLC method was developed for the determination of Dothiepin HCl (DTH) in pure and tablet dosage form. Methods: The method was developed by using Phenomenex C18 (250 X 4.6 mm, 5 μm) and the mobile phase composed of buffer (0.1M sodium acetate): acetonitrile in the ratio of 50:50 v/v. The buffer pH was adjusted to 2.8. The retention time for Dothiepin HCl was found to be 3.44 min. Linearity range for Dothiepin HCl was found to be 10-60 μg/mL and the regression equation was found to be y=14691x-12844. % RSD for intra- and inter-day precision was found to be 0.27% and 0.84%. Average mean recovery was found to be 99.94%. LOD and LOQ values obtained for Dothiepin HCl were found to be 0.825 μg/mL and 2.498 μg/mL respectively. Conclusion: The results are analysed statistically and are found to be satisfactory. Hence this method can be successfully employed for analysis of Dothiepin HCl in tablet dosage form.
Key words: Dothiepin HCl, RP-HPLC, Linearity, Dosage form, Precision.