Development and Validation of Forced Degradation Studies of Atazanavir Using RP-HPLC and Characterization of Degradants by LC-MS/MS”

摘要

The main objective of current study is to develop and validate RP-HPLC, simple, precise, accurate and specific chromatographic method for the determination of atazanavir and degradation products are characterized by LC-MS/MS in tablets. A high performance liquid chromatography instrument and Hypersil BDS, 150 x 4.6 mm, 5 were used for determination of atazanavir. Mobile phase as a acetonitrile and buffer in the ratio of 1:1V/V .The flow rate of 1.0mL/min was set with isocratic, the temperature of column compartment maintained at 30°C and Ultra violet detection done at 248nm wavelength. The atazanavir eluted at 3 minutes and then run time was set as about 10 minutes. The correlation coefficient (≥ 0.999) shows the linearity of response against concentration over the range of 20 to 150%. The observed result shows that the method is rapid, precise, accurate and simple. The method was validated as per ICH guidelines.