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DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL METHODS FOR ASSAY OF EFAVIRENZ IN PHARMACEUTICAL FORMULATIONS

Sowjanya S*, Devadasu CH, Rajya Lakshmi N, Laxmi Narayanamma CH

A simple and specific visible spectrophotometry method was developed and validated in order to assay of Efavirenz in pharmaceuticals .The analogy of the method was based on the reactivity of primary aromatic amine which is resulted due to the hydrolysis of Efavirenz and treated with 2 % w/v solution of p-dimethylamino benzaldehyde, a yellow colour chromogen is obtained as a Schiff’s base which can be estimated at 406 nm using a spectrophotometer serves the basis for proposed method. The linearity for spectrophotometric methods was established it obey beer’s law in the concentration range 100-500 µg/ml and the correlation coefficient was found as 0.9995. Limit of detection and limit of quantitation was found to be 0.125 and 0.375 for the developed method. The % RSD was found as 0.688 and 0.87 for intra-assay (repeatability) and intermediate precision respectively. The % recovery of the proposed method lies in the range 100.98-101.47. The method is simple and suitable for the determination of Efavirenz in formulation. Keywords: Efavirenz, spectrophotometry, p-dimethylamino benzaldehyde, validation.

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