Abstract

REVIEW ARTICLE: DEVELOPMENT AND VALIDATION OF UV VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF EMTRICITABINE IN BULK DOSAGE FORM

*S. Srilakshmi and T. Priyanka

Abstract

Simple, rapid, sensitive, precise and specific UV spectrophotometric method for the determination of Emtricitabine (EMB) in bulk drug and pharmaceutical dosage form was developed and validated. A simple double beam UV spectrophotometric method has been developed and validated with different parameters such as linearity, precision, repeatability, limit of detection (LOD), Limit of Quantification (LOQ), accuracy as per ICH guidelines. UV-visible spectrophotometric method, measurement of absorption at the maximum wavelength in 10 ml methanol and volume make with water solvent system as reference EMB were found to be at 225 nm respectively. The drug obeyed the Beer’s law and showed good correlation. Beer’s law was obeyed in concentration range 3-21 for Emtricitabine respectively with correlation coefficient was 0.999. The LOD and LOQ of EMB were found to be 0.3900(μg/ml) and 1.2936(μg/ml) respectively. Percentage Assay of EMB in tablets. The proposed method is precise, accurate and reproducible and can be used for routine analysis of EMB in bulk and tablet dosage form.

Keywords: Emtricitabine, method development, validation, UV Spectroscopy.