Method development and validation of anti-protozoal agent- Nitazoxanide by RP-HPLC and it’s stability related impurities studies

Authors

  • Patel Dhruvi Ben Omega College of Pharmacy, Edulabad, Ghatkesar, Affiliated to Osmania University, Hyderabad, Telangana, India
  • H. Parameshwar Omega College of Pharmacy, Edulabad, Ghatkesar, Affiliated to Osmania University, Hyderabad, Telangana, India
  • A.V. Jithan Omega College of Pharmacy, Edulabad, Ghatkesar, Affiliated to Osmania University, Hyderabad, Telangana, India
  • C.A Ranjani Omega College of Pharmacy, Edulabad, Ghatkesar, Affiliated to Osmania University, Hyderabad, Telangana, India
  • G. Shirisha Omega College of Pharmacy, Edulabad, Ghatkesar, Affiliated to Osmania University, Hyderabad, Telangana, India
  • Sana Yasmeen Omega College of Pharmacy, Edulabad, Ghatkesar, Affiliated to Osmania University, Hyderabad, Telangana, India

Keywords:

Nitazoxanide, Method development, Method Validation, Retention time.

Abstract

A simple and new Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed for the simultaneous estimation of Nitazoxanide in Pure form and Marketed Pharmaceutical Dosage form. The separation involved an isocratic elution of this component on Symmetry C18 (4.6 x 150mm, 5mm, Make: XTerra) using a mobile phase composition Methanol: Phosphate buffer = 60:40. The flow rate was 1.0 ml/min and the analyte monitored at 242nm. The performance of the method was validated according to the present ICH guidelines for specificity, linearity, accuracy, precision and robustness. Retention times of Nitazoxanide were found to be 2.96 min respectively. The percentage recoveries for Nitazoxanide were found to be within the limits i.e. 97-102% respectively. Calibration curves were linear with coefficient correlation between 0.990 to 0.999. Typically the regression equation for the calibration curve was found to be y = 26326x + 38649 (R2=0.995) Nitazoxanide respectively. The developed method can be successfully employed for routine quality control analysis of Nitazoxanide marketed formulation.

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Published

2022-08-29

Issue

Vol. 8 No. 3 (2022): Vol 8. No 3 (2022) Volume - 8 Issue - 3

Section

Articles

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