Article · Volume 53, Issue 2 · pp. 310–315

Method Development and Validation for the Estimation of Dothiepin Hydrochloride by using RP-HPLC in PURE and Tablet Dosage Form

Prasanthi Thayi¹, Lakshman Rao Atmakuri², Nandini Mandada³, Hemanth Mandava³, Bhuvaneswari Mandru³, Chaitanya Manne³

¹Department of Pharmaceutical Analysis, Associate Professor, V. V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna District.
²Department of Pharmaceutical Analysis, Professor and Principal, V. V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna.
³Student, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna District, Andhra Pradesh, INDIA.

Abstract

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.

Keywords: Dothiepin HCl; RP-HPLC; Linearity; Dosage form; Precision

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