Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF DARUNAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Hrutuja M. Pawar*, Dr. Bhupendra L. Deore and Gayatri K. Sapkale

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Abstract

An RP-HPLC method has been developed and validated for the determination of Darunavir in bulk and tablet formulation. The RPHPLC analysis was performed on the Fortis C18 column (150 mm x 4.6 mm i.d., 2.5μm) in isocratic mode, at 300c using methanol: water (75:25v/v) pH adjusted to 8.0 with triethylamine as the mobile phase; flow rate was set at 1.0 mL/min. The detection was carried out at 268nm. The retention time for Darunavir was found to be found to be 3.840± 0.02 min. Darunavir followed linearity in the concentration range of 30 – 70μg/mL (r2 = 0.999). The method has successively been applied for the determination of Darunavir in marketed formulation. There was no interference from the excipients routinely present in the tablet. The drug content for Darunavir was found to be 99.28 % ± 0.48. The accuracy of the method was studied by the recovery studies at three different levels i.e. 80 %, 100 %, and 120 % level. The % recovery was found to be within the limits of the acceptance criteria within the range of 98.46 – 100.18 %. The precision of the method was studied as the repeatability of the sample application, intra-day, and inter-day precision. The results were examined as %RSD values of the concentration of drugs determined. The low value of %RSD (less than 2) indicates the high precision of the method. The method proved to be adequately sensitive as indicated by low values of LOD and LOQ.

Keywords: Darunavir, HIV, AIDS, Analytical method development, HPLC, Method validation.