High Performance Liquid Chromatography (HPLC) is one of the effective separation analytical tools to determine and
quantitate the impurities. By using HPLC, we can separate a mixture of compounds to identify and quantify into individual
components. In literature survey, various quantification methods are available for the determination of dolutegravir in combined
dosage form. The present research paper describes a simple, accurate and precise reversed-phase high performance liquid
chromatography (RP-HPLC) method for quantification of dolutegravir in bulk and pharmaceutical dosage form (tablets). This
method is validated for different analytical performance parameters like linearity, precision, accuracy, limit of detection, limit of
quantification, and robustness were determined according to the International Conference of Harmonization (ICH) Q2B guidelines.
Detection was carried out at 256 nm. The mobile phase used as pH-3.6 phosphate buffer:acetonitrile in ratio of (40:60) v/v with
flow rate of 1 ml/min. All the parameters of validation were found in the acceptance range of ICH guidelines. The method was
found to be linear and correlation coefficient obtained was 0.9996. The system suitability parameters were found to be within the
limits. The proposed method was validated in terms of linearity, range, accuracy, precision, specificity, robustness and stability
studies and the method is successfully applies to the estimation of dolutegravir in tablet dosage form. Hence the developed method
can be adapted to regular quality control analysis.
Key words: Reversed-Phase High-Performance Liquid Chromatography, dolutegravir, validation, linearity, accuracy.
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