A Novel RP- HPLC Method with Core Shell Tecnology Column for Assay Analysis of Darunavir Ethanolate in Tablet Dosage Form

Authors

  • S. M. Ramdharane  Research Scholar, Faculty of science, Pacific Academy of Higher Education and Research University , Udaipur, Rajasthan, India
  • Ritu Vays  PhD. Guide, Faculty of science, Pacific Academy of Higher Education and Research University , Udaipur , Rajasthan, India
  • K. S. Nimavat  PhD. Guide, Govt. Science College, Gandhinagar, Gujarat, India3

Keywords:

Darunavir Ethanolate, ICH guidelines, Validation, RP-HPLC, Core shell Technology

Abstract

High performance liquid Chromatography method was developed and validated for the detection of Darunavir Ethanolate in tablet dosage form. The method was carried out on a Sunshell C18 Column (100 × 4.6 mm id, 2.6µ) maintained at 30ºC. The mobile phase consisted of water-acetonitrile (60 + 40, vol./vol.) pumped at a flow rate 1.0 mL/min. PDA detection was at 265 nm. The chromatography separation was obtained with a retention time of 2.4 min, and the Method was linear in the range of 1-25 mg/mL (r2 = 0.9997). Specificity which also showed that there was no interference of the excipients. The method was validated for linearity, precision, accuracy, robustness, The developed method, after being validated was successively applied to the analysis. of tablet formulations. Hence the method can be used for routing analysis.

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International Journal of Scientific Research in Science, Engineering and Technology

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Published

2017-12-31

Issue

Volume 3, Issue 8, November-December-2017

Section

Research Articles

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How to Cite

[1]
S. M. Ramdharane, Ritu Vays, K. S. Nimavat, " A Novel RP- HPLC Method with Core Shell Tecnology Column for Assay Analysis of Darunavir Ethanolate in Tablet Dosage Form, International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 3, Issue 8, pp.896-899, November-December-2017.