Development and Validation of New Rp-Hplc Method for the Assay of Nevirapine and its Related Substances in Tablet Dosage form.

Abstract

The study of literature survey, it was found that there are some analytical methods reported for nevirapine assay and fewer methods for the determination of impurities by RP-HPLC in pharmaceutical dosage forms. Nevirapine is increasingly finding use in treatment of anti-HIV as well as in combination therapy. So there is not only need to develop a newer analytical method for the estimation of nevirapine, but also to identify and quantify its process related impurities and its degradants. The present work is aimed at Method development (By reverse phase HPLC) and Validation of the developed method (By using following parameters). Nevirapine is an anti-HIV of the non-nucleoside reverse transcriptase inhibitor (NNRTI). It is more potent than zidovudine on HIV-1, but do not inhibit HIV-2. Viral resistance to these drugs develops by point mutation and cross resistance is common. Literature reports some UV-visible spectrophotometric, RP-HPLC methods for the quantification of the nevirapine in bulk drugs and formulations. But only few methods are available for determination of related substances and degradants. The linear response was obtained with acceptable correlation co-efficient. No significant interference seen in specificity study. The method was fully validated for both assay of nevirapine and related substances with the precision, specificity/forced degradation study, accuracy, linearity, ruggedness, robustness, solution stability and filter study. The values obtained for nevirapine, related compound A, B and impurity C was within the acceptance criteria. Hence the findings indicate that the developed method is precise, specific, accurate, linear, robust and rugged. This method can be used for the routine analysis of nevirapine and its related substances in tablet dosage for