Development and Validation of New Analytical Methods for the Estimation of Ritonavir in Bulk and Pharmaceutical Dosage Forms
Journal Title: International Journal of Pharma Research and Health Sciences - Year 2017, Vol 5, Issue 5
Abstract
Pharmaceutical analysis occupies a pivotal role in statuary certification of drugs and their formulations either by the industry or by the regulatory authorities. The current good manufacturing practices (CGMP) and the Food Drug Administration (FDA) guidelines insist for adoption of sound methods of analysis with greater sensitivity and reproducibility. Therefore, the complexity of problems encountered in pharmaceutical analysis with the importance of achieving the selectivity, speed, low cost, simplicity, sensitivity, specificity, precision and accuracy in estimation of drugs. In the present investigation potent drug namely Ritonavir only few analytical methods were reported and hence there is wide scope for the development of new analytical methods for its quantitative analysis. All the developed methods are complimentary to each other and the proposed methods can be used as alternative methods to reported ones thereby providing a wide choice for routine determination of the Ritonavir in bulk and pharmaceutical preparation. In the present investigation, a simple, sensitive, precise and accurate RP-HPLC method was developed for the quantitative estimation of Ritonavir in bulk and pharmaceutical dosage forms. The results expressed for HPLC is promising. In addition to positive requirements for analytical methods, the striking advantage of all the presently developed methods is that they are economical. And method is validated in terms of accuracy, precision, linearity, and limit of detection, limit of quantitation, and robustness. This method can be used for the routine determination of Ritonavir in bulk and pharmaceutical dosage forms.
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