Development and validation of RP- HPLC method with UV detection to determine and quantify dimenhydrinate in human plasma

作者:Zeb-un-nisa; Shoaib Muhammad Harris; Ali Syed Imran; Rizvi Mehwish; Ali Huma; Fatima Rasheeda; Khan Maqsood Ahmed; Kashif Sadia Suri
来源:Pakistan Journal of Pharmaceutical Sciences, 2018, 31(3): 979-984.

摘要

A simple, sensitive and rigorous method for estimation of dimenhydrinate in human plasma was searched and its validation was carried out. LLE (Liquid-Liquid extraction) of analyte with mixture of Hexane and ethyl acetate (1:1 v/v) was carried out for the preparation of Plasma Samples, Chromatographic elution of dimenhydrinate was conducted in human plasma and mobile phase with C-18 bonda Pack column (10 mu m; 250 x 4.6), using a mobile phase consisting a solution of ammonium bicarbonate in water and methanol at a flow rate of 0.5ml /minute with UV detection at 229 nm. The resolution of dimenhydrinate was well performed from plasma components. This method was validated and exhibited linearity with concentration range of 6 to 380ng/mL of dimenhydrinate in plasma. The Intra day precision was 89.2 to 96.89% and Inter day precision was 88.6% to 93.26%, the average recovery of dimenhydrinate was 97.02%. The efficacy of extraction was proved by above mentioned results. 2ng/ml and 6ng/ml, were appraised as the LOD and LOQ of dimenhydrinate, stability studies disclosed that dimenhydrinate exhibited stability in Plasma after Freeze & thaw cycles and upon -20 degrees C storage, the method was developed well.

  • 出版日期2018-5