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NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DOLUTEGRAVIR SODIUM IN SYNTHETIC MIXTURE BY USING RP-HPLC
Shalini*, Pushpendra Soni, Lavakesh Kumar Omray
Radharaman Institute of Pharmaceutical Sciences, Bhopal
A novel isocratic reversed phase high performance liquid chromatographic method was developed and validated for the determination of human immune deficiency virus drug Dolutegravir (DGV) present in formulation known as Instgra which consists 50 mg of DGV. Chromatographic separation achieved isocratically on thermo C18 column (5Î¼m, 150mm x 4.60mm) and acetonitrile: methanol in the ratio of 50:50 (v/v) as the mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 264 nm. The retention times for DGV was found to be 4.274 Â± 0.3 min. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the ICH guidelines. The method was linear in the concentration range of 5-25 Î¼g/ml with correlation coefficient of 0.999. The mean recoveries obtained for DGV 99.71% and RSD was less than 2. The correlation coefficients for all components are close to 1. Developed method was found to be novel, accurate, precise, selective and rapid for estimation of DGV.
Keywords: RP-HPLC, Dolutegravi, Method development, Validation.
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