Liquid chromatography atmospheric pressure chemical ionization tandem mass spectrometry method for the quantification of pregabalin in human plasma

Nirogi, Ramakrishna; Kandikere, Vishwottam; Mudigonda, Koteshwara; Komarneni, Prashanth; Aleti, Raghupathi

doi:10.1016/j.jchromb.2009.10.004

Cited by 34 publications

(13 citation statements)

References 18 publications

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“…Literature survey has revealed few analytical methods of its determination in bulk drugs and pharmaceutical formulations [5,[8][9][10][11][12] but all of these methods are very expensive as they require long and tedious pretreatment of the samples, including extraction with solvent and derivatization for its analysis, so there was a need for the development of a simple, economical and least time consuming HPLC/ UV method for the quantification of PGB in bulk, pharmaceutical formulations and human plasma. Hence, an attempt has been made to develop a novel, sensitive, simple, efficient, economic, selective having a short time and lower limits of quantification and detection.…”

Section: Resultsmentioning

confidence: 99%

“…Nigori et al [12] reported a high-performance liquid chromatography tandem mass spectrometry method in which analyte was separated by isocratic mobile phase and analyzed by MS/MS in the multiple reaction monitoring method by means of the respective [M+H](+) ions. These all were quite exclusive methods because of their extended and monotonous pretreatment of the samples, extraction with solvent and derivatization for the analysis of pregabalin.…”

Section: Introductionmentioning

confidence: 99%

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Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

M¹

2014

Pharm Anal Acta

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

M¹

2014

Pharm Anal Acta

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“…Similar to gabapentin, other than to adjust dosing during renal failure or to assess compliance, pregabalin is not a good candidate for routine TDM. Plasma and serum concentrations of pregabalin can be determined by HPLC following derivitization [141] or by LC/MS/MS [142]. …”

Section: Pregabalinmentioning

confidence: 99%

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

Krasowski

2010

Pharmaceuticals

103

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Abstract:In the past twenty years, 14 new antiepileptic drugs have been approved for use in the United States and/or Europe. These drugs are eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, rufinamide, stiripentol, tiagabine, topiramate, vigabatrin and zonisamide. In general, the clinical utility of therapeutic drug monitoring has not been established in clinical trials for these new anticonvulsants, and clear guidelines for drug monitoring have yet to be defined. The antiepileptic drugs with the strongest justifications for drug monitoring are lamotrigine, oxcarbazepine, stiripentol, and zonisamide. Stiripentol and tiagabine are strongly protein bound and are candidates for free drug monitoring. Therapeutic drug monitoring has lower utility for gabapentin, pregabalin, and vigabatrin. Measurement of salivary drug concentrations has potential utility for therapeutic drug monitoring of lamotrigine, levetiracetam, and topiramate. Therapeutic drug monitoring of the new antiepileptic drugs will be discussed in managing patients with epilepsy.

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“…25) Sophisticated LC MS/MS methods have also been used for quantification of PGB, GBP and VGB in plasma or serum. [26][27][28] The analytical method for drug determination in formulation development or routine quality control purposes has to fulfil several criteria. Ideally it requires relative low sample volume and simple sample preparation procedure.…”

Section: Pregabalin ((3s)-3-(aminomethyl)-5-methylhexanoic Acid) (Pgbmentioning

confidence: 99%

A Simple High-Throughput Method for Determination of Antiepileptic Analogues of γ-Aminobutyric Acid in Pharmaceutical Dosage Forms Using Microplate Fluorescence Reader

Martinc

Vovk

2013

CHEMICAL & PHARMACEUTICAL BULLETIN

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Pregabalin (PGB), gabapentin (GBP), and vigabatrin (VGB) are structural analogues of γ-aminobutyric acid used for the treatment of different forms of epilepsy. Their analytical determination is challenging since these molecules have no significant UV or visible absorption. Several derivatization methods have been developed and used for their determination in bulk or pharmaceutical dosage forms. We aimed to develop a highthroughput method using a microplate reader with fluorescence detection and simple derivatization with fluorescamine. Obtained method involves derivatization step of only 5 min at room temperature and simultaneous measurements of 96 samples (λ ex 395, λ em 476 nm) thus rendering excellent high-throughput analysis. The method was found to be linear with r 2 >0.998 across investigated analytical ranges of 0.75 to 30.0 µg/ mL for PGB, 2.00 to 80.0 µg/mL for GBP, and 1.50 to 60.0 µg/mL for VGB. Intraday and interday precision values did not exceed 4.93%. The accuracy was ranging between 96.6 to 103.5%. The method was also found to be specific since used excipients did not interfere with the method. The robustness study showed that derivatization procedure is more robust than spectrofluorimetric conditions. The developed high-throughput method was successfully applied for determination of drug content and dissolution profiles in pharmaceutical dosage forms of studied antiepileptic drugs.

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Liquid chromatography atmospheric pressure chemical ionization tandem mass spectrometry method for the quantification of pregabalin in human plasma

Cited by 34 publications

References 18 publications

Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

A Simple High-Throughput Method for Determination of Antiepileptic Analogues of γ-Aminobutyric Acid in Pharmaceutical Dosage Forms Using Microplate Fluorescence Reader

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