DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF AGOMELATINE IN BULK AND A TABLET DOSAGE FORM

  • Firake Bhushan M. Faculty of Pharmacy, Bhagwant University, Ajmer, Rajasthan, India.
  • Pathak Pranjalee V. JSPM’s Jayawantaro Sawant College of Pharmacy & Research, Hadapsar, Pune, Maharashtra, India.
  • Dorik Pallavi K. JSPM’s Jayawantaro Sawant College of Pharmacy & Research, Hadapsar, Pune, Maharashtra, India.
  • Siddaiah M. Jawaharlal Nehru Technological University, Anantapur. Andhra Pradesh, India
DOI: https://doi.org/10.32553/jbpr.v10i1.828
Keywords: Agomelatine, Validation, UV Spectrophotometric method

Abstract

UV spectrophotometry is an analytical technique used routinely for qualitative and quantitative assay due the low cost and reliability during analysis. An simple, efficient, rapid, sensitive, precise and economical UV Spectrophotometric method has been developed for estimation of agomelatine from bulk and pharmaceutical formulation. The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines.  The λmax of agomelatine in acetonitrile was found to be 229.6 nm. The analytical method validation parameters linearity, precision, accuracy, robustness were studied according to International Conference on Harmonization guidelines. Pure drug concentration was prepared in the range of 1-10 μg/ml and the linear regression analysis data showed good linear relationship with correlation coefficient value 0.9937. The precision of the method was studied as an intra- day, inter-day variations with value less than 2 % RSD. The limit of detection and limit of quantitation were found to be 0.577 and 1.248 μg/ml, respectively. Recoveries were found to be in the range of 100.815 to 101.744 % and % RSD was less than 2 %. This proposed UV spectroscopic method is simple and suitable for routine analysis.

Keywords: Keywords: Agomelatine, Validation, UV Spectrophotometric method

Published
2021-02-09
How to Cite
M., F. B., V., P. P., K., D. P., & M., S. (2021). DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF AGOMELATINE IN BULK AND A TABLET DOSAGE FORM. Journal of Biomedical and Pharmaceutical Research, 10(1), 22-25. https://doi.org/10.32553/jbpr.v10i1.828
Issue
Vol. 10 No. 1 (2021)
Section
Articles

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