Development and validation of a UV-Visible method for the determination of the active principle Efavirenz in tablets

Abstract

Methods proposed by pharmacopeias to control the quality of Efavirenz, an antiretroviral drug used in the treatment of AIDS are based on expensive equipment which are most of the time not available in African countries. To solve this issue, using UV-visible spectrophotometry, a cheap and easy-to-use device available in many laboratories on the African continent; a sensitive, reliable, simple and rapid method has been validated for the determination of the active substance Evafirenz in Efavirenz tablets, to control their quality by checking its dosage. The accuracy profile approach was adopted. The response function gave a correlation coefficient R² = 0.9987. The detection and quantification limits were 0.15625 μg / mL and 0.515625 μg / mL, respectively. The acceptability limit has been set at 15%. The tolerance limits for the different concentration levels (80, 100 and 120%) are represented respectively as follows: lower limits 86.2; 90.3 and 96.1%; upper limits 100.2; 106.3 and 113.7%. The tolerance limits are within the acceptability limits for values around 100% concentration (7 μg / mL). Therefore, the method was declared valid and reliable for the analysis of Efavirenz in Efavirenz tablets and could routinely be used in laboratories for the quality control of EFAVIRENZ drug.

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Keywords: Efavirenz, accuracy profile, spectrophotometry, pharmaceutical formulation