Quantitative estimation of cabotegravir & rilpivirine in tablet Dosage forms by RP-HPLC method
Keywords:
Cabotegravir and Palonosetron, RP-HPLC, ICH Guidelines, ValidationAbstract
A novel, precise, accurate, rapid and cost effective isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the estimation of Cabotegravir and Rilpivirine in bulk and pharmaceutical dosage forms. The drugs were estimated using Phenomenex Gemini C18 (4.6mm×150mm, 5µm) particle size column. A mobile phase composed of methanol and Water in proportion of 32:68 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 240nm. The linearity range obtained was 30-70µg/ml for Cabotegravir and 10-50µg/ml for with retention times (Rt) of 3.297min and 5.405min for Cabotegravir and Rilpivirine respectively. The correlation coefficient values were found to be 0.999 & 0.999. Precession studies showed % RSD values less than 2 % for both the drugs in all the selected concentrations. The percentage recoveries of Cabotegravir and Rilpivirine were found to be 100.1873% for Cabotegravir and 100.748% for Rilpivirine respectively. The assay results of Cabotegravir and Rilpivirine were found to be 99.82%. The limit of detection (LOD) and limit of quantification (LOQ) were 2.6µg/ml and 7.8µg/ml for Cabotegravir and 3.4µg/ml 10.2µg/ml for Rilpivirine respectively. The proposed method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.