Stability indicating RP-HPLC method for determination of nevirapine in pure and tablet form

Minaketan Sahoo; B. V. V. Ravi Kumar; Niraj K. Tripathy; Saroj K. Patro

Abstract

Stability indicating RP-HPLC method for determination of nevirapine in pure and tablet form

Author(s): Minaketan Sahoo, B. V. V. Ravi Kumar, Niraj K. Tripathy and Saroj K. Patro

In the present study, determination of Nevirapine in pure and tablet form by stability indicating RP-HPLC method was developed. The drug was resolved using a mobile phase of buffer (pH 2.5) and methanol in the ratios of 50:50 on a Thermo BDS Hypersil C18 column in isocratic mode. The retention time of nevirapine was 8.583 min. The % RSD was less than 2 in intraday, inter-day precision and in each parameter of robustness. The Lower limit of Detection and the limit of quantitation were found to be 0.2563μg/ml and 0.7767μg/ml respectively which indicates that the method is sensitive. The percentage of average recoveries was obtained in the range of 98 to 102%. Further forced degradation studies of Nevirapine were carried out under acidic, alkaline and hydrolytic conditions as per SIAM (Stability Indicating Assay Methods). The drug is more stable in the acidic and basic medium than the hydrogen peroxide medium. The developed method is simple, new, accurate, precise, robust, sensitive and reproducible and can be utilized for routine laboratory analysis of pure and tablet dosage form.

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