کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
7626284 | 1494579 | 2018 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Extractability-mediated stability bias and hematocrit impact: High extraction recovery is critical to feasibility of volumetric adsorptive microsampling (VAMS) in regulated bioanalysis
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کلمات کلیدی
LLOQvolumetric absorptive microsamplingFDAVAMSULOQGLPEMALLELC–MS/MS - LC-MS / MSEuropean Medicines agency - آژانس دارویی اروپاUS Food and Drug Administration - اداره غذا و داروی ایالات متحدهFeasibility assessment - ارزیابی امکان سنجیinternal standard - استاندارد داخلیLiquid–liquid extraction - استخراج مایع مایعGood Laboratory Practice - تمرین خوب آزمایشگاهیupper limit of quantification - حد بالای اندازه گیریlower limit of quantification - حد پایین کمیت سنجیRelative humidity - رطوبت نسبیRecovery - ریکاوریhematocrit - هماتوکریت%CV - ٪رزومهquality control - کنترل کیفیت
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Volumetric absorptive microsampling (VAMS), a new microsampling technique, was evaluated for its potential in supporting regulated bioanalysis. Our initial assessment with MK-0518 (raltegravir) using a direct extraction method resulted in 45-52% extraction recovery, significant hematocrit (Ht) related bias, and more importantly, unacceptable stability (>15% bias from nominal concentration) after 7-day storage. Our investigation suggested that the observed biases were not due to VAMS absorption, sampling techniques, lot-to-lot variability, matrix effect, and/or chemical stability of the compound, but rather the low extraction recovery. An effort to improve assay recovery led to a modified liquid-liquid extraction (LLE) method that demonstrated more consistent performance, minimal Ht impact (Ht ranged from 20 to 65%), and acceptable sample stability. The same strategy was successfully applied to another more hydrophilic model compound, MK-0431 (sitagliptin). These results suggest that the previously observed Ht effect and “instability” were in fact due to inconsistent extractability, and optimizing the extraction recovery to greater than 80% was critical to ensure VAMS performance. We recommend adding Ht-independent recovery as part of feasibility assessment to de-risk the long-term extractability-mediated stability bias before implementing VAMS in regulated bioanalysis.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 156, 15 July 2018, Pages 58-66
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 156, 15 July 2018, Pages 58-66
نویسندگان
Iris Xie, Yang Xu, Melanie Anderson, Ming Wang, Lingling Xue, Sheila Breidinger, Dina Goykhman, Eric J. Woolf, Kevin P. Bateman,