Development and validation of stability indicating RP- HPLC method for the simultaneous estimation of atazanavir and cobicistat in tablets


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Volume :

5

Issue :

4

Abstract :

The objective of the current study was to develop and validate a rapid, precise, specific reverse phase HPLC method for the stability indicating analysis of atazanavir and cobicistat in tablets in its dosage form. The determination is done for the active pharmaceutical ingredient in its pharmaceutical dosage form. The dosage was subjected to analytical studies as per international conference on harmonization (ICH) prescribed. It was found that atazanavir and cobicistat is very sensitive to different conditions. The chromatographic conditions were optimized using the samples. Regression analysis shows an r value (correlation coefficient) 0.999 & 0.997 respectively for drugs. The satisfactory chromatographic separation, with good peak shapes were achieved on Zorbax X DBC-8; 150X4.6mm, 5µm. The method employed an isocratic elution and the detection wave-length was set at 235nm nm. With mobile phase ph 4.2 Buffer: ACN (70:30) with a flow rate of 1.0 ml/min. The developed RP-LC method was validated with respect to linearity, accuracy, precision, robustness and the degradations at different selected parameters.
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