DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLET DOSAGE FORM
Keywords:Darunavir ethanolate (DRV), UV Spectrophotometry, Absorbance maxima method, Area under curve
Two simple, precise and economical UV methods have been developed for the estimation of Darunavir ethanolate (DRV) in bulk and pharmaceutical dosage form. Method A is Absorbance maxima method, which is based on measurement of absorption at maximum wavelength, 266 nm. Method B is area under curve (AUC), in the wavelength range of 255-275 nm. Linearity for detector response was observed in the concentration range of 3-18 Î¼g/ml for the both methods. The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. The accuracy of the methods was assessed by recovery studies and was found to be 100.07% and 99.58% for Method A and Method B respectively. The results were validated statistically as per ICH Q2 R1 guidelines and were found to be satisfactory. The proposed methods were successfully applied for the determination of DRV in tablet dosage form.
Babu A, G. Raveendra Lakshmana Rao and J. Venkateswara Rao Development and Validation of Novel HPLC method for Estimation of Darunavir in Pharmaceutical Formulation Int J of Res in Pharmacy and Chemistry 2013;3(2).
Reddy BVR, Jyothi G, Reddy BS, Raman NVVSS, Reddy KSC, Rambabu C. Stability-indicating HPLC method for the determination of darunavir ethanolate. J Chromatogr Sci 2013;51(5):471-6.
Bhavini N, Patel BN, Simultaneous S. And Validation of Darunavir and Ritonavir In Binary Mixture By Liquid Chromatography International Journal of PharmTech Research. J Chromatogr Sci 2012;4(4):1450-6.
Bhavini N. Patel, Bhanubhai N. Suhagia, Chaganbhai N. Patel RP-HPLC Method Development and Validation for Estimation of Darunavir in Tablet Dosage Form. Int J of Pharmacy and Pharm Sci 2012;4(3):178-81.
Raveendra B, Ramprasad A, Jayachandra R, New RP, Srinivasu L, Asian J, et al. Ganduri, Peddareddigari, for the Determination of Darunavir in Tablet Dosage form Pharm. J Res 1 2011:10-4.
ICH Q2 R1 Text on Validation of Analytical Procedures International conference on Harmonized Tripartite Guideline November. J Chromatogr Sci 2005:1-17.