DEVELOPMENT, VALIDATION & STRESS DEGRADATION STUDIES OF DARUNAVIR BY REVERSE PHASE-HIGH PER-FORMANCE LIQUID CHROMATOGRAPHGY (RP-HPLC)
Keywords:
Darunavir; HPLC, Tablet formulationAbstract
A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the estimation of Darunavir in pharmaceutical dosage form. The mobile phase consisted of 80:20% (v/v) of Methanol & 0.1% ortho-phosphoric acid was used and operated on isocratic mode. The flow rate is 1.0 mL/min. Chromatographic determination of Darunavir was performed on Agilent Polaris C18 column (150 X 4.6 mm id, ODS 2,5µ m). The wavelength of detection is 265nm. The injection volume is 20µL. The retention time of Darunavir is 2.42 ± 0.01minutes. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability. The influence of Acid, Alkaline, Oxidative stress, Photolytic stress condition on Darunavir was studied. Results indicated completed degradation in Alkaline medium. The proposed method has been successfully used for the estimation in tablet dosage forms.
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