METHOD DEVELOPMENT AND VALIDATION OF ATAZANAVIR IN PHARMACEUTICAL FORMULATION BY RP-HPLC METHOD
Journal Title: Int J of Pharm Res & Analy - Year 2015, Vol 5, Issue 1
Abstract
Present work describes method for determination of Atazanavir in solid dosage form. The estimation was carried out on a Waters ODS (C18) RP Column, 250 mm x 4.6 mm.column with a mixture of Buffer (triethylamine & pH adjusted to 3.0 with glacial acetic acid) and Acetronitrile in a ratio of 80 : 20(v/v) as mobile phase. UV detection was performed at 212 nm. The method was validated for linearity, accuracy, precision, specificity, limits of detection and quantitation and robustness as per ICH norms. The developed and validated method was successfully used for indicating the stability of the drug and quantitative analysis of commercially available dosage form. The retention time was 3.1min. The flow rate was 1.0 mL min-1. The calibration curve was linear in the range of 10-100 μg/ml, for Atazanavir (API) with correlation coefficient (r2) of 0.998. The LOD and LOQ values were found to be 0.05 g/ml and 0.15 g/ml. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the estimation of Atazanavir in pure and in capsule dosage form.
Authors and Affiliations
Nazia Hasan*, , Shyamala, , JVC Sharma , P Vishnu Priya
Keywords
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