ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DOLUTEGRAVIR IN PURE FORM BY USING UV SPECTROPHOTOMETRY
P. T. Nagaraju*, M. Jayasree, M. Mounica, M. Kumari, N. Shahida Begum and M. Gnaneshwar
ABSTRACT
A simple, specific, accurate and precise spectroscopy method was developed and validated for the estimation of Dolutegravir in Pure form. The Standard solution was prepared by weighing 100 mg of Dolutegravir in 100 ml volumetric flask with dilute dimethyl formamide The final Standard solution was made to produce 1000 ?g / ml with dilute dimethyl formamide Further dilutions were prepared as per procedure and were scanned at 260 nm. The linearity was found in the concentration range of 10-60 ?g / ml. The Correlation coefficient was 0.999. The regression equation was found to be Y = 0.0552 X – 0.336. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation and ruggedness,robustness. The limit of detection and limit of quantitation for estimation of Dolutegravir was found to be 0.09 (?g / ml) and 0.27 (?g / ml), respectively. The percentage recovery of Dolutegravir was found to be in the range of 98.49 ± 0.0001– 101.3 ± 0.003. Proposed method can be successfully applied for the quantitative determination of Dolutegravir in pharmaceutical Pure form.
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