Monday , 17 June 2024

Development and validation of a Sensitive Bio analytical method for the quantitative estimation of Desvenlafaxine in human plasma samples by LC–MS/MS: Application to bioequivalence study

Narendra Kumar Reddy Kolli*1, Swetha Polagani1, Bharghava Bhushana Rao Pathange2
1Sri Vani School of Pharmacy, Chevuturu, Vijayawada, AP. India.
2VVIPS, Gudlavalleru, Krishna Dt, AP, India

A Novel sensitive and selective ultra-high performance liquid chromatography-coupled to mass spectroscopy (LCMS/MS) method was developed and validated for the quantification of Desvenlafaxine in human plasma ,when Desvenlafaxine D6  used as internal standard. HPLC analysis was carried out on Thermo-BDS Hypersil 3µ,C8 50*4.6 mm with  mobile phase 5 ml Ammonium Acetate : Methanol (20:80) (v/v) and flow rate of 0.800 mL/min. Method development comprises of:-Tuning parameters of the Analyte , ISTD  Optimization of Source parameters and Mass parameters Optimization of Chromatographic conditions, Optimization of extraction procedure (LPE).  System Suitability, Mobile Phase stability: Accuracy , Precision and specified analytical method for quantification were found to give accurate and precise results within the range of Desvenlafaxine 1.002ng/mL to 1000.165 ng/mL, the specified analytical methods for quantification of Desvenlafaxine were found to give reproducible results when samples are re-injected. Stock solutions of Desvenlafaxine and DesvenlafaxineD6 were stable for 20 hours 19minutes when kept at room temperature. The specified analytical method for quantification of Desvenlafaxine was found to have freeze and thaw stability for 05 cycles for Desvenlafaxine in biological matrix containing K2EDTA human plasma as the anticoagulant .Desvenlafaxine is found to be meeting the acceptance criteria for stability when kept on bench top for 18hours 25mins in the biological matrix containing K2EDTA as an anticoagulant.

Keywords: Desvenlafaxine, Desvenlafaxine D6, Human K2EDTA plasma, LC-MS/MS, 5mL Ammonium Acetate: Methanol  (20:80) (v/v).

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