The Development and Validation of Stability Indicating HPLC Method for Estimation of Darunavir

  • Anurruddha R. Chabukswar Professor - Pharmaceutical Chemistry, Dr. Vishwanath Karad MIT World Peace University, School of Pharmacy, Kothrud, Pune- 411038, Maharashtra, India
  • Ayushi S Gadekar MAEERS Maharashtra Institute of Pharmacy, Kothrud, Pune -411038, Maharashtra, India

Abstract

To develop a new simple, precise and accurate HPLC method for estimation of Darunavir in tablet formulation. An isocratic, HPLC method was developed using C-18, 50 x 3 mm, 3.5 µm (X-Terra MS, Waters) column 0.1 % Acetic acid in water: ACN (63:37 v/v) as mobile phase at flow rate of 1.0 ml/min at detection wavelength of 267  nm. The retention time (RT) of drug was 3.123± 0.034 min . The method was validated with respect to linearity, precision, assay, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 5-30 μg/ml concentrations with a correlation coefficient(R 2) of 0.9995.The developed method was found to be simple, sensitive, selective, accurate, and precise for analysis of Darunavir  and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form.


Keywords: High performance liquid chromatography (HPLC), Darunavir, method development, Validation.

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Author Biographies

Anurruddha R. Chabukswar, Professor - Pharmaceutical Chemistry, Dr. Vishwanath Karad MIT World Peace University, School of Pharmacy, Kothrud, Pune- 411038, Maharashtra, India

Professor - Pharmaceutical Chemistry, Dr. Vishwanath Karad MIT World Peace University, School of Pharmacy, Kothrud, Pune- 411038, Maharashtra, India

Ayushi S Gadekar, MAEERS Maharashtra Institute of Pharmacy, Kothrud, Pune -411038, Maharashtra, India

MAEERS Maharashtra Institute of Pharmacy, Kothrud, Pune -411038, Maharashtra, India

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How to Cite
Chabukswar, A. R., & Gadekar, A. (2019). The Development and Validation of Stability Indicating HPLC Method for Estimation of Darunavir. Journal of Drug Delivery and Therapeutics, 9(4), 65-71. https://doi.org/10.22270/jddt.v9i4.3148