Abstract

UV-VISIBLE SPECTROMETRIC METHOD AND VALIDATION, COMPATIBILITY STUDIES OF NEVIRAPINE CUBOSOME FORMULATION

R. Swathi*, M. Sunitha Reddy

ABSTRACT

A simple, sensitive, accurate, precise and rapid UV spectrophotometric method was developed and validated for the estimation of Nevirapine in pure form and its formulation. For the estimation of Nevirapine, at absorption maxima about 312 nm by using0.1N HCL. The developed method was used to estimate the total drug content in Cubosome formulation of Nevirapine and recovery studies were carried out. The proposed method was linear over the range of 5-25 μg/ml with correlation co-efficient (r2) of 0.996 and mean recovery for Nevirapine was 100.18%. Thus suggesting the validity of the method noninterference of formulation excipients in the estimation. The proposed method can be successfully applied for the analysis of liquid formulation. Compatibility must be established between the active ingredient and other excipients to produce a stable efficacious, attractive and safe product. In this report FTIR studies were performed and major peaks were determined by the (FTIR bruker-alpha, Tokyo, Japan) will show band shift and broadening compare to spectra of pure drug. To study the interaction between Nevirapine, selected excipients (Glycerol monooleate, Sodium alginate, Guar gum, Carbopol 934 B.P. IR spectra of Nevirapine bands were found at 3296 cm-1 for O-H stretch, 3060 cm-1 for C-H stretch, 1587 cm-1 for C=C Stretch ,1077 cm-1 for O-H stretch, 823 cm-1 for C-H bending. This confirms the identity of Nevirapine.

Keywords: Spectrophotometric determination, Nevirapine, Validation, Compatibility studies, Nevirapine, Excipients.