Analytical Method Development and Validation for the Estimation of Sugammadex

  • Rajashree Mashru Faculty of Pharmacy, G. H. Patel Building, Donor`s Plaza, The M.S. University of Baroda, Vadodara, 390002, INDIA
  • Hemangi Parekh Faculty of Pharmacy, G. H. Patel Building, Donor`s Plaza, The M.S. University of Baroda, Vadodara, 390002, INDIA
  • Parin Chokshi Faculty of Pharmacy, G. H. Patel Building, Donor`s Plaza, The M.S. University of Baroda, Vadodara, 390002, INDIA

Abstract

A simple, precise, accurate, specific RP-HPLC method developed for sugammadex in bulk and simulated mixture. Chromatographic separation is achieved by C18 column (250 x 4.6 mm, 5µ) in isocratic mode. The optimized mobile phase consists of acetonitrile and double distilled water in ratio of 20:80%v/v at a flow rate of 0.5mL/min and sugammadex was monitored at 210nm. Retention time of the drug was found to be 3.39min. The linearity obtained in range of 50 – 250 µg/mL.  %RSD mean for precision and %Recovery mean of the sugammadex were found to be 0.63 and 99.04% - 99.84% respectively. Stability indicating nature of RP-HPLC method was established by applying the degradation condition. The results indicate that developed RP-HPLC method would be suitable for estimation of drug in presence of degradant product. The above developed method was validated according to ICH guideline.


 Keywords: Sugammadex, Assay, Simulated Mixture, Forced Degradation, Validation.

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Mashru R, Parekh H, Chokshi P. Analytical Method Development and Validation for the Estimation of Sugammadex. JDDT [Internet]. 15Jan.2020 [cited 28Mar.2020];10(1):52-9. Available from: http://jddtonline.info/index.php/jddt/article/view/3842