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Vol. 32 No. 9 (2020): Vol 32 Issue 9, 2020

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Development and Validation of RP-Chiral HPLC Method for Determination of (R)-Enantiomer Excess Content in Efavirenz

https://doi.org/10.14233/ajchem.2020.22755
Ch. Ramesh
Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam-530003, India ; Laurus Labs Ltd., Visakhapatnam-531021, India
Dharmasoth Rama Devi
A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
M.N.B. Srinivas
Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam-530003, India ; Laurus Labs Ltd., Visakhapatnam-531021, India
S. Radha Krishna
Laurus Labs Ltd., Visakhapatnam-531021, India
Nagaraju Rajana
Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam-530003, India
K. Basavaiah
Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam-530003, India

Corresponding Author(s) : Nagaraju Rajana

nagarajrajana@gmail.com

Asian Journal of Chemistry, Vol. 32 No. 9 (2020): Vol 32 Issue 9, 2020

Abstract

A simple, specific, linear, accurate and precise reverse phase chiral HPLC method was developed for the separation of efavirenz enantiomers by using the Lux Amylose-2 column containing amylose tris(5-chloro-2-methyl phenyl carbamate) as a stationary phase. The mobile phase consists of 0.1 % formic acid in water and acetonitrile (55:45, v/v). The flow rate was kept at 1.0 mL/min and the detection wavelength used 252 nm and the column temperature was set at 25 ºC. The limit of detection was 0.01 mg/mL and the limit of quantification was 0.04 mg/mL. The linearity calibration curve of (R)-enantiomer was shown well from the range of 0.04 mg/mL to 0.4 mg/mL. The values of the correlation coefficient were 0.999 and 0.999 for (R)-enantiomer and (S)-efavirenz, respectively. The percentage recoveries of (R)-enantiomer from efavirenz drug substance were ranged from 93.5% to 107.5%. The results demonstrated that developed RP-chiral HPLC method was simple, precise, robust and applicable for the estimation of (R)-enantiomer in efavirenz API. This method was validated in as per ICH Q2 (R1) and USP validation of compendial methods <1225>.

Keywords

Efavirenz Efavirenz (R)-Enantiomer (R)-Enantiomer RP-chiral HPLC RP-chiral HPLC Validation Validation
Ramesh, C., Rama Devi, D., Srinivas, M., Radha Krishna, S., Rajana, N., & Basavaiah, K. (2020). Development and Validation of RP-Chiral HPLC Method for Determination of (R)-Enantiomer Excess Content in Efavirenz. Asian Journal of Chemistry, 32(9), 2208–2212. https://doi.org/10.14233/ajchem.2020.22755
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