• ashish tale
• manoj kadam
• minal ghante
• rohan shellar

A new simple, precise and economical RP-HPLC method has been developed for the estimation of Darunavir ethanolate (DRV) in bulk and pharmaceutical dosage form. Separation of the drug was achieved on reverse phase Hi Q Sil C18 (250×4.6mm, 5.0 μm) column, using a mobile phase consisting of Acetonitrile: methanol in the ratio of (90:10 % v/v) with pH 5.0 at 1.0 ml/min flow rate and the effluents were monitored at 266 nm. Retention time was found to be 3.03 min for DRV. Linearity was observed in the concentration range between 15-90 µg/ml (r2 = 0.9996). The developed method was validated statistically for linearity, accuracy, precision and selectivity. The accuracy of the method was assessed by recovery studies and was found to be 99.65% and the % RSD from recovery studies was also found less than 1. The method was successfully validated as per ICH guidelines in terms of precision, robustness and recovery.

Method development, Validation, RP-HPLC, Darunavir ethanolate, Recovery, %RSD and ICH guidelines.

"“DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLET DOSAGE FORM”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 2, page no.101-109, February-2019, Available :http://www.jetir.org/papers/JETIR1902B14.pdf

"“DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLET DOSAGE FORM”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 2, page no. pp101-109, February-2019, Available at : http://www.jetir.org/papers/JETIR1902B14.pdf