DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLETS
Objective: A new precise, accurate, sensitive and robust RP-HPLC method was developed for estimation of darunavir ethanolate in bulk and tablets.
Methods: The chromatographic separation was achieved on Enable C18 column (250 Ã— 4.6 mm, 5 Âµm) at an ambient temperature. The mobile phase consists of acetonitrile and 0.01M potassium acetate buffer, pH 5.1 (75:25 v/v) was at the flow rate 1 ml/min and UV detection was done at 268 nm.
Results: The method was linear over the concentration range of 40-90 Âµg/ml (r2= 0.998) of the drug. The percentage content was found in darunavir ethanolate 99.19Â±0.58 in tablets. The low value of the drug %RSD (0.11) indicates that reproducibility of this method. Low value of LOD and LOQ suggests the sensitivity of the method.
Conclusion: It can be concluded from the results that the proposed RP-HPLC method was found to be rapid, simple, accurate, robust and precise for the analysis of darunavir ethanolate in bulk and tablet dosage form. The developed method can be applied in routine analysis of this drug in the pharmaceutical industry.
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