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  • October 2018 issue published
  • Dear Researcher, It Pleased to inform you that, Asian Journal of Pharmaceutical Education and Research, has successfully launch Volume 7, Issue 4 (October Issue). You can find the article on http://ajper.com/current_issue.php Article also invited for the Next coming Issue from your side. For More details Visit: www.ajper.com
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Abstract

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

ABSTRACT

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 (5μm, 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 ± 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 μg/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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