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

Indian Journal of Pharmaceutical Education and Research

  • Prasanthi Thayi1Department of Pharmaceutical Analysis, Associate Professor, V. V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna District.
  • Lakshman Rao Atmakuri2Department of Pharmaceutical Analysis, Professor and Principal, V. V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna.
  • Nandini Mandada3Student, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna District, Andhra Pradesh, INDIA.
  • Hemanth Mandava3Student, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna District, Andhra Pradesh, INDIA.
  • Bhuvaneswari Mandru3Student, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna District, Andhra Pradesh, INDIA.
  • Chaitanya Manne3Student, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna District, Andhra Pradesh, INDIA.

Volume 53 Issue 2 Pages 310-315

DOI: 10.5530/ijper.53.2.39

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
IJOPP

Loading…