Abstract

SIMULTANEOUS SPECTROPHOTOMETRIC ESTIMATION OF TENOFOVIR DISOPROXIL FUMARATE & EFAVIRENZ IN BULK AND PHARMACEUTICAL DOSAGE FORMS

*Swathi K. and Ranjeetha AR.

ABSTRACT

A novel, simple, accurate and precise Zero order derivative spectroscopic method was developed and validated for the simultaneous estimation of Tenofovir Disoproxil Fumarate & Efavirenz in bulk and Pharmaceutical dosage forms and has an absorption maximum at 259 and 247nm respectively for Tenofovir disoproxil fumarate & Efavirenz in Methanol : water (50:50). The Linearity was found to be in the concentration range 5-30μg/ml & 2-12 μg/ml and the correlation coefficient was found to be 0.9996 & 0.9995 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be y = 0.0246x + 0.0016 & Y=0.0246x + 0.0032, the % recovery values were found to be within 99.91-100.14% & 98.43-98.98% showed that the method was accurate. The LOD and LOQ were found to be TDF 0.3266 and 0.9800 mcg / ml EFV 0.3879 & 0.1293 mcg / ml respectively. The % RSD values were less than 2. The method has been validated according to ICH guidelines for linearity, accuracy, precision, robustness, ruggedness. Limit of detection and limit of quantitation. Proposed method was successfully applied for the quantitative simultaneous estimation of Tenofovir Disoproxil Fumarate & Efavirenz in bulk and pharmaceutical dosage form.

Keywords: Tenofovir disoproxil fumarate, Efavirenz, Zero order derivative Spectroscopy, Methanol: water (50:50), Linearity, Precision, Reproducibility and Accuracy.