Development and Validation of New Stability Indicating RP-HPLCMethod for the Assay of Atazanavir in Pure and Dosage Forms

[摘要] Reversed phase liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the determination of Atazanavir in pure and formulations. The studies on selection of mobile phase and flow rate basing on peak parameters were extensively carried for the development of the proposed method. The mobile phase composition of buffer (pH-4.5) and acetonitrile in the ratio of 750:250 v/v Atazanavir peak was eluted at void volume with long retention time. The regression value for Atazanavir was found to be 0.9964 exhibiting the response, in the linear from range 2.0-10.0 μg/mL respectively. The % RSD for precision is < 2.0 confirming that the developed RP-HPLC method is sufficiently precise and the total run time required for the method is only 4.007 min. for eluting Atazanavir. The accuracy of the developed method was demonstrated at three concentration levels in the range of 50–150 %. The developed method was said to be simple, selective and accurate and is useful for the assay of Atazanavir in dosage forms and can be further employed in the quality control analysis of bulk manufacturing and formulations units.

[学科分类] 药理学