DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF ATAZANAVIR SULPHATE IN BULK AND TABLET DOSAGE FORM

Authors

  • Minal R. Ghante STES's Smt Kashibai Navale College of Pharmacy, Kondhwa, Pune 410048, India.
  • Manoj M. Kadam STES's Smt Kashibai Navale College of Pharmacy, Kondhwa, Pune 410048, India.
  • Sanjay D. Sawant STES's Smt Kashibai Navale College of Pharmacy, Kondhwa, Pune 410048, India.
  • Rohan S. Shelar STES's Smt Kashibai Navale College of Pharmacy, Kondhwa, Pune 410048, India.

Keywords:

Atazanavir sulphate, Absorption maxima, Area under Curve, Anti-HIV drug, ICH guidelines

Abstract

Two simple, accurate, precise and cost effective UV-Spectrophotometric methods have been developed for estimation of Atazanavir sulphate (ATV), an anti-HIV drug, in bulk and pharmaceutical dosage form. Method A is Absorbance maxima method, which is based on measurement of absorption at maximum wavelength, 247nm. Method B is Area under Curve (AUC), in wavelength range of 240-254nm. The linear responses were observed in the range of 5- 40 μg/ml for both the methods, with the regression coefficient of 0.9996 and 0.9997 respectively. The accuracy of the methods was assessed by recovery studies and was found to be 100.56% and 100.86% respectively. The developed methods were validated for different parameters like linearity, accuracy (recovery), precision and specificity, as per the ICH Q2 R1 (International Conference for Harmonization) guidelines and were found to be satisfactory. These methods can be used for the determination of Atazanavir sulphate in bulk and formulation without interference of the excipients.

Downloads

Download data is not yet available.

References

M. Padmalatha, K. Vanitha Prakash, Validated, Reversed Phase High Performance Liquid Chromatography method for the estimation of atazanavir sulfate in pharmaceutical formulations. Oriental J of Chemistry 2010;26(1):123-7.

S G Khanage, V K Deshmukh, P B Mohite. Development of Derivative Spectrophotometric Estimation of Atazanavir sulfate in Bulk Drug and Pharmaceutical Dosage Forms. Int J Pharm and Health Sci 2010;1(3):149-54.

S K Konidala, Sujana K. Development and Validation of UV Spectrophotometric method for determination of ATV in Bulk and Formulation. IJPPS 2012;4(3).

ICH Q2 R1 Text on Validation of Analytical Procedures International conference on Harmonized Tripartite Guideline November 2005;1-17.

Beckett A H, Stenlake J B. Practical Pharmaceutical Chemistry. 4th edition, New Delhi:CBS Publishers and Distributors 2002;2:275-88.

Published

01-07-2014

How to Cite

Ghante, M. R., M. M. Kadam, S. D. Sawant, and R. S. Shelar. “DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF ATAZANAVIR SULPHATE IN BULK AND TABLET DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 7, July 2014, pp. 351-3, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/2031.

Issue

Section

Original Article(s)