DEVELOPMENT, VALIDATION & STRESS DEGRADATION STUDIES OF DARUNAVIR BY REVERSE PHASE-HIGH PER-FORMANCE LIQUID CHROMATOGRAPHGY (RP-HPLC)
Keywords:Darunavir; HPLC, Tablet formulation
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.
Drug bank. Available from: http: www.drugbank.ca/drug/db01264. [Last accessed on 2015 Jun 10].
Ghosh AK, Dawson ZL, Mitsuya H "Darunavir, “A conceptually new HIV-1 protease inhibitor for the treatment of drug-resistant HIV". Bioorg. Med. Chem;2007; 15(24):7576–80.
S. Meyer, H.Azojin, D. Surleraux, TMC 114, a novel human immunodeficiency virus type 1 protease inhibitor-resistance viruses, including a board range of clinical isolates. Antimicrob Agents Chemother, 49 (2005), 2314-2321.
N. King , M. Jeyabaran, E. Naliyaika, P. Wifgerinck, M. Bethune, C.Schiffer, Sturctural and Thermodynamics Basis for the Binding of TMC 114, a Next-Generation Human Immunodeficiency Virus Type 1 Protease Inhibitor. J.Virol, 78(2004), 12012-12021.
Clotet,N. Bellos, J.M. Molina, D. Cooper, J.C. Goffard, A. Lazzarin, A. Wohtmann, C. Katlama, T. Wilkin. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials Lancet 369 (2007) 1169-1178.
"Instrumental Methods of Analysis" by Galen W. Ewing , Mc Graw Hill International Edition, p.48, 378.
Amit Patel, Ami Patel and Ashlesha Makwana. (2013). An ESI-LC-MS/MS method for simultaneous Estimation of Darunavir and Ritonavir in human plasma. International Journal of Research in Pharmaceutical and Biomedical science. 4(4), 1138-47.
Nageshwar Rao, Ram chandra, Santosh kumar. RP-HPLC speration and characterization of unknown impurties of a novel HIV-1 protease inhibitor Darunavir by ESI-MS and 2D NMR spectroscopy. J Pharm Biomed Anal 2013; 75: 186-191.
Avolio, M. Siccardi, M. Sciandra, L. Baietto. HPLC-MS method for the simultaneous quantification of the new HIV protease inhibitor darunavir and other anti-retroviral agents in plasma of HIV-infected patients. J Chromatogr B. 859 (2007) 234-240.
Hari Babu k, Sisla Ramakrishna , Kiran kumar, Ramesh, Sita Devi. HPTLC method for determination of Darunavir in rat plasma and its application to pharmaceutics studies. J liq Chromatogra Releated Technol 2013; 36:169-179.
Ana Carolina Kongana, Herida Regina. Development and validation of infra-red spectroscopy method for determination of Darunavir in tablet. Phy Chem 2013; 3:1-6.
G. Raveendra Babu, A. Lakshmana Rao and J. Venkateshwara Rao.(2013). Development and validation of novel HPLC method for estimation of Darunavir in Pharmaceutical formulations. International Journal of Research in Pharmacy and chemistry.3(2), 438-443.
Bhavani N.Patel, B.N. Suhagia (2012). Simultaneous Determination and validaton of Darunavir Ethanolate and Ritonavir in binary mixture by Liquid chromatography. International Journal of Pharm Tech Reseach. 4(4), 1450-56.
Raveendra B. Ganduri, Ramprasad A.Lanka, Srinivasu Pamidi, Jayachandra R. Peddareddigari, JVLNS Rao (2011). New RP-HPLC Method for the Determination of Darunavir in Tablet dosage form. Asian j. Pharm.Res. 1(1), 10-14.
L. Satyanarayana, S.V. Naidu, M. Narasimha Rao, Alok kumar and K.Suresh (2011). The Estimation of Darunavir in Tablet Dosage form by RP-HPLC. Asian J.Res.Pharm.Sci. 1(3),74-76.
Manisha B. Mane, Pranali J. Gaikawad, AnujaV. Patil, Aashish S. Mogale (2013). RP-HPLC Method for Determination of Darunavir in Bulk and Pharmaceutical Preparations. Int.J.Pharm.Sci. 21(2), 20-23.
Gholve Sachin B, Asware Baburao S., Kadam Shrihari C., Bhusnure Omprakash G. and Thonte Sanjay S (2015). De-velopment and validation of a simple UV spectrophotometric method for the determination of Darunavir ethanolate both in bulk and marketed dosage formulations. World Journal of pharmaceutical research. 4(3), 1276-83.
S. Leonard, A. Schepdael, T. Lvanyi, I. Lazar, J. Rosier, M. Vanstockem (2005). Development of a capillary electrophoretic method for the separation of diasteroisomers of a new human immunodeficiency virus protease inhibitor. Electrophoresis. 26;627.
International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), November 2005.
Authority of the United States Pharmacopeial Convention. The United States Pharmacopeia (USP34), National Formulary (NF 29). Maryland.,2011.
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