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Quantification of dapsone in human plasma by using UPLC-MS/MS technique

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Author Affiliations

  • 1Synergen Bio Private Limited, Unit Nos. 101 to 104 and 309 to 311, Sai Chambers, 302, Old Mumbai – Pune, India Highway, Wakadewadi, Shivajinagar, Pune, Maharashtra - 411003, India
  • 2Synergen Bio Private Limited, Unit Nos. 101 to 104 and 309 to 311, Sai Chambers, 302, Old Mumbai – Pune, India Highway, Wakadewadi, Shivajinagar, Pune, Maharashtra - 411003, India

Res.J.chem.sci., Volume 14, Issue (1), Pages 1-7, February,18 (2024)

Abstract

To validate the method for determination of dapsone in K2EDTA human plasma using high performance liquid chromatography method with tandem mass spectrometry. Bioanalytical method was developed at Bioanalytical Research of Synergen Bio Pvt. Ltd. and validated as per method validation SOP. 0.200mL plasma was aliquoted and 0.050mL of internal standard dilution was added to it, except in blank in which 0.050mL of diluents was added and vortexed all the samples. 0.200 mL of 5mM Ammonium Acetate was added to all samples and vortexed for few seconds. Conditioning and equilibration were done with 1 ml of Methanol. Equilibration with 1ml of HPLC Water. Samples were loaded on Cartridges and washing with 1 ml HPLC water then by 5% MeOH in HPLC water. Samples were eluted with 1ml elution solution (70:30: Acetonitrile: 5mM Ammonium Acetate Solution). Transfer the samples into pre-labelled autosampler vials. Linearity of Calibration standard were linear in range of 5.000–3000.000ng/mL for Dapsone. The method validated at current regulatory requirements for sensitivity, selectivity, accuracy and precision, linearity, matrix effect, autosampler carryover effect, cross reactivity and stability of bench top, freeze thaw, autosampler and stability in whole blood etc. However, Recovery for dapsone and its internal standard were found precise, consistent and reproducible. (i.e. not more than 100%). The validated method has been used for the quantification dapsone in Human plasma and can be applied to BA/BE studies of dapsone.

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