Monday , 17 June 2024

Analytical Method Development and Validation for the Estimation of Efavirenz by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Gobala Krishnan P*1, Munisekhar V, Ranjit Singh B. Rathore
Department of Pharmaceutical Chemistry, Vagdevi college of Pharmacy & Research centre, Nellore, Andhra Pradesh, India.

The chromatographic conditions were successfully developed for the separation of Efavirenz  by using KromosilColumn (100-5 C18.60×4.6mm), flow rate was 1ml/min, mobile phase ratio was Acetonitril: Phosphate buffer PH 5.0: Methanol (40:50:10 v/v), detection wavelength was 247 nm. The Spectroscopic method was done in solvent using methanol and the instrument lab India 3000+ with UV win software. The instrument used was WATERS HPLC Auto Sampler, Separation module 2675, UV detector, Empower-software version 2. The retention time were found to be 3.221 min. The system suitability parameters for Efavirenz such as theoretical plates and tailing factor were found to be 3015. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Efavirenz was found in the concentration range of 29.69 μg/ml to 237.52 μg/ml and correlation coefficient (r2) was found to be 0.999 respectively, % recovery was found to be 99.4% respectively. %RSD for repeatability and precision was found to be <2. LOD values were 0.024 μg/ml and LOQ value were  0.066 respectively for Efavirenz.
Keywords: Efavirenz, HPLC, LOQ, ICH guidelines

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