Abstract

Pharmaceutical analysis simply means analysis of pharmaceuticals. Webster’ dictionary defines a pharmaceutical is a medical drug. A more appropriate term for a pharmaceutical is active pharmaceutical ingredient (API) or active ingredient to distinguish it from a formulated product or drug product is prepared by formulating a drug substance with inert ingredient (excipient) to prepare a drug product that is suitable for administration to patients. A simple and reproducible HPLC procedure was developed and validated as per ICH guidelines for the estimation of Atazanavir and Ritonavir. Quantitative estimation of Atazanavir and Ritonavir was estimated by RP-HPLC using ACN: 0.1% Ortho phosphoric acid (45:55 %v/v) as a mobile phase and Hypersil column (250mm×4.6mm, 5μ) as a stationary phase and the peaks were observed at 240nm which was selected as a wavelength for quantitative estimation. After development of the method it was validated for specificity, system suitability, accuracy, linearity, precision, ruggedness and robustness. The value of theoretical plates, tailing factor, retention time and peak area was found to be within limits, hence it is concluded that the system is suitable to perform assay. The method was found to be specific because it did not show any interference with placebo and blank..

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