A Novel Ultra Performance Liquid Chromatography-PDA Method Development and Validation for Darunavir in Bulk and Its Application to Marketed Dosage Form

Abstract

A BSTRACT Aims and Objective: The aim of this study was to develop and validate a novel ultra-performance liquid chromatographic method for estimation of darunavir in a bulk and tablet dosage form. Materials and Methods: The chromatographic separation was achieved using DIKMA Endoversil (2.1mm x 50mm, 1.7 µm) column. A mixture of 40% buffer (0.1% octa sulfonic acid) and 60% acetonitrile was used as a mobile phase with the isocratic elution mode and eluent was monitored at 281nm using UV detector. The method was continued and validated in accordance with International Conference on Harmonization Guidelines. Validation study revealed the specificity and reliability of the method. Results: In this method, darunavir was eluted with retention time of 0.516 min. Calibration curve plots were found linear over the concentration ranges 10–50 μg/mL for darunavir. Limit of detection was 0.02 μg/mL and limit of quantification was found 0.07 μg/mL. The present method was also found stable in force degradation study. Conclusion: The empirical evidences of all the study results revealed the suitability of the estimation of darunavir in bulk and tablet dosage form without any interference from the excipients.

Quality by design tool–evaluated stability‐indicating ultra‐performance liquid chromatography method for the determination of drugs (ritonavir and darunavir) used to treat the human immunodeficiency virus/acquired immunodeficiency syndrome

“…So far, only a few analytical techniques have been published for the chromatographic analysis of combination formulation, either separately or together. According to the literature review (Abduljalil & Badhan, 2016;Chiranjeevi & Channabasavaraj, 2011;Ettaboina et al, 2022;Grace & Parthiban, 2022;Jagadeeswaran et al, 2012;Kashish et al, 2020;Kavitha, 2020;Kumar et al, 2016;Lathouwers et al, 2011;Masaaki et al, 2021;Mishra & Shrivastav, 2014;Muchakayala et al, 2022;Pappula & Naresh, 2022;Patel et al, 2013;Paul et al, 2021;Raju et al, 2021;Rezk et al, 2009;Sabyasachi et al, 2021) none of these methods was found suitable for a stability-indicating analysis for quality control use.Thelonger run time used for quantification makes methods time consuming and cost-effective. In general, the technique should be enhanced or its robustness should be proven using the quality by design (QbD) approach, according to the present regulatory criteria, which are unambiguous.…”