An Improved LC-ESI-MS/MS Method to Quantify Pregabalin in Human Plasma and Dry Plasma Spot for Therapeutic Monitoring and Pharmacokinetic Applications

Abstract

Proposed method involves simple and rapid steps of sample processing that do not require a precolumn or postcolumn derivatization procedure. The method is suitable for routine pharmacokinetic analysis and therapeutic monitoring of PGB.

New Methods Used in Pharmacokinetics and Therapeutic Monitoring of the First and Newer Generations of Antiepileptic Drugs (AEDs)

“…The described assays were proved to be appropriate also for the analysis of PGB in serum and blood [146][147][148]. Moreover, the validated methods for determination of the drug in plasma were reported, including LC-FLD method after derivatization with 4-fluoro-7-nitrobenzofurazan [150] and highly sensitive LC-MS/MS method [151].…”

“…Isolation of both drugs from biological matrix before chromatographic analysis was performed using protein precipitation with acetonitrile [78,147] and methanol [146], or SPE using cation exchange cartridges [151]. The LC-MS/MS methods were also reported for determination of PGB in DBS/DPS [151,152]. The drug was isolated from the matrix using LLE with a mixture of methyl tert-butyl ether and diethyl ether [151] or ethyl acetate [152].…”

“…The LC-MS/MS methods were also reported for determination of PGB in DBS/DPS [151,152]. The drug was isolated from the matrix using LLE with a mixture of methyl tert-butyl ether and diethyl ether [151] or ethyl acetate [152].…”

Development and clinical applications of the dried blood spot method for therapeutic drug monitoring of anti‐epileptic drugs

“…Information about internal standards, analytical methods and ranges, sampling methods, punch sizes, paper types, sample and injection volumes, drying times, DBS sample extraction methods, effects of Hct levels and results of comparisons between DBS and plasma were summarized (Table ). In 26 studies, 19 types of AEDs were measured using the DBS method ; among them, 9 studies analysed >2 AEDs . The most frequently analysed AED was carbamazepine (n = 8); others included lamotrigine (n = 7), valproic acid (n = 7), levetiracetam (n = 3), phenytoin (n = 3), topiramate (n = 3), carbamazepine epoxide (n = 2), gabapentin (n = 2), phenobarbital (n = 2), pregabalin (n = 2), clobazam (n = 1), clonazepam (n = 1), ethosuximide (n = 1), felbamate (n = 1), monohydroxycarbamazepine (n = 1), nitrazepam (n = 1), rufinamide (n = 1), vigabatrin (n = 1) and zonisamide (n = 1).…”

“…Only one bioequivalence study in healthy volunteers compared the C dps and C p of pregabalin and found that C dps could be converted to C p without introducing any statistical bias . Another study compared C dps and C dbs after adjustment for Hct levels and found a high correlation ( r 2 = 0.977) .…”