Asian Journal of Pharmaceutical Analysis
  • Year: 2024
  • Volume: 14
  • Issue: 4

Analytical method development and validation of nitazoxanide by RP-HPLC method in API and tablet dosage forms

  • Author:
  • Devshree Yashwantbhai Patel1,*, Javesh Kashinath Patil2, Harsha Vasudev Chaudhari3, Ruchita M Kothari4
  • Total Page Count: 6
  • Page Number: 211 to 216

1Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal's College of Pharmacy, Shahada, Dist - Nandurbar, 425409, Maharashtra, India

2Associate Professor, Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal's College of Pharmacy, Shahada, Dist. - Nandurbar, 425409, Maharashtra, India

3Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal's College of Pharmacy, Shahada, Dist - Nandurbar, 425409, Maharashtra, India

4Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal's College of Pharmacy, Shahada, Dist - Nandurbar, 425409, India

*Corresponding Author E-mail: devshree744@gmail.com

Online published on 15 April, 2025.

Abstract

A Simple, precise and accurate RP-HPLC method was developed for determination of of Nitazoxanide in API and tablet dosage forms. The chromatographic separation was done on Cosmosil C18 Column (250mm × 4.6mm,5μm) using mobile phase MEOH+ 0.05% (OPA with TEA) Water (70+30% v/v) at flow rate 0.7ml/min and wavelength detection 340nm.The retention time for Nitazoxanide was found to be 4.333 min. Linearity was observed in the range10-50μg/ml (y=55.38 × -37.01 and R2; = 0.9976). The LOD and LOQ was found to be 0.4258 and 1.289 respectively. The Precision as indicated by repeatability study was having %RSD less than 2. The accuracy, intraday and interday were also found to be less than 2. Hence the proposed method is successfully developed and validated.

Keywords

Nitazoxanide, RP-HPLC