DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE IN COMBINED DOSAGE FORM USING QUALITY BY DESIGN APPROACHAbstract
A new, simple, rapid, accurate, and economical method has been developed for the simultaneous estimation of Lamivudine and Tenofovir Disoproxil Fumarate in formulation by using a quality by design approach. Design expert software was used for QbD analysis. 03 level factorial quadratic design models were used to analyze the response. The model generated was found to be significant. The optimized conditions of factors were concentration 10ug/ml and wavelength (λmax) 272 nm for LAM and 259 nm for TDF. The distilled water was used as a solvent for analysis. The linearity was observed in the concentration range of 02-100 µg/ml for Lamivudine and Tenofovir Disoproxil Fumarate, both drugs. The simultaneous equation method was used for estimation, and the method was validated as per ICH guidelines. The recovery of Lamivudine and Tenofovir Disoproxil Fumarate was found in the range of 98.90-100.77% and 101.63-102.43%. The stability testing was done as per ICH guidelines. The developed method may be used by industries for analyzing their products.
A. J. Asnani *, S. M. Mohurle and K. Pratyush
Priyadarshini J. L. College of Pharmacy Electronic Zone M. I. D. C., Nagpur, Maharashtra, India.
08 June 2020
10 October 2020
03 May 2021
01 June 2021