Optimization of an HPLC Method for Determination of Gabapentin in Dosage Forms through Derivatization with 1-Fluoro-2,4-dinitrobenzene

Souri, Effat; Jalalizadeh, Hassan; Shafiee, Abbas

doi:10.1248/cpb.55.1427

Cited by 29 publications

(15 citation statements)

References 22 publications

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“…1) The analytical method development for PGB, GBP and VGB determination is challenging since these molecules have no significant UV or visible absorption. Several derivatization methods have been proposed [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] and used for their determination in bulk or pharmaceutical dosage forms, plasma, serum, and urine. These methods employed derivatization reagents such as fluorescamine, [2][3][4][17][18][19] 7-chloro-4-nitrobenzofurazan, [5][6][7] 1-fluoro-2,4-dinitrobenzene, 8) o-phtaldialdehyde, 9,10) 2,4,6-trinitrobenzene sulfonic acid, 11,12) and 9-fluorenylmethylchloroformate.…”

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

confidence: 99%

“…2,[5][6][7]17,19) Moreover, HPLC 3,[8][9][10][11][12][13][14]18) and capillary electrophoresis (CE) methods 4) using precolumn derivatization with either UV or fluorescent detector were also used.…”

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

confidence: 99%

“…In addition method should meet validation criteria in terms of precision, accuracy, robustness etc., and most of all it has to offer highthroughput. So far developed methods for determination of PGB, 3,5,17,19) GBP, 2,7,8,15,16,18,[20][21][22][23][24] and VGB 2,6,7,18,25) use from a few µL to approximately 1 mL of sample. The sample preparation is the time-consuming step in derivatization methods and in case of PGB, GBP, and VGB derivatization can take from few seconds to 50 min.…”

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

confidence: 99%

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

confidence: 99%

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

confidence: 99%

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

confidence: 99%

See 1 more Smart Citation

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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“…26 A few analytical methods have been reported for the determination of GB in pharmaceutical preparations in the literature including spectrofluorimery and spectrophotometry, 27,28 flow analysis, 29 CE 30 and HPLC. 31,32 In this study, a highly sensitive spectrofluorimetric method with high reproducibility has been developed for the assay of GB in pharmaceutical preparations by means of the derivative formed with NBD-F, which is a specific reagent in the analysis of primary and secondary aliphatic amines.…”

Section: Introductionmentioning

confidence: 99%

Sensitive Spectrofluorimetric Method of Analysis for Gabapentin in Pure and Pharmaceutical Preparations

Ulu

Kel

2011

Chin. J. Chem.

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Highly sensitive spectrofluorimetric method was developed and validated for the determination of gabapentin in pure and pharmaceutical preparations. The method was based on nucleophilic substitution reaction of gabapentin with 4-fluoro-7-nitrobenzofurazan (NBD-F) in an alkaline medium (pH 9.5) to form a highly fluorescent derivative that was measured at 521 nm after excitation at 458 nm. The factors affecting the reaction was carefully studied and optimized. The method was successfully validated for linearity, limit of detection, limit of quantification, accuracy, precision, robustness and specificity. Under the optimized conditions, linear relationship with good correlation coefficient (0.9998) was found between the relative fluorescence intensity and gabapentin concentration in the range of 10-100 ng•mL -1 . The limit of detection and limit of quantification were 0.43 and 1.30 ng•mL -1 , respectively.The proposed method was successfully applied to the determination of gabapentin in its pharmaceutical capsules.The results obtained by the proposed method were comparable with those obtained by the official method. Statistical comparison by t-and F-tests revealed that there was no significant difference between the results of the two methods with respect to mean values and standard deviations at the 95% confidence level.

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“…Gabapentin has demonstrated analgesic effects in patients with chronic neuropathic pain states [2]. Several analytical methods have been reported for the determination of gabapentin in pharmaceutical preparations such as high performance liquid chromatography (HPLC) [3][4][5][6][7][8], capillary electrophoresis [9,10], chemiluminometry [11], potentiometry [2], voltammetry [12], spectrofluorimetry [13,14], spectrophotometry [15][16][17][18][19][20], automated spectrophotometry using piezoelectric pumping [21] and fluorimetry using sequential injection [22].…”

mentioning

confidence: 99%

Non-aqueous titrimetric assay of gabapentin in capsules using perchloric acid as titrant

Abdulrahman

Basavaiah

2011

CI&CEQ

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Two simple, rapid, accurate and inexpensive methods using visual and potentiometric titrimetric techniques are described for the determination of gabapentin (GBP) in bulk drug as well as in capsules. The methods are based on the neutralization reaction of the primary amino group of GBP with acetous perchloric acid as titrant in anhydrous acetic acid medium. The end point was detected either visually using crystal violet as indicator or potentiometrically using a modified glass electrode SCE electrode system. Both methods are applicable over the range 1.0-16.0 mg of GBP and the titration reaction follows a 1:1 stoichiometry. The methods were successfully applied to the determination of GBP in capsules. The validity of the proposed methods was further ascertained by parallel determination by a reference method and by recovery studies via standard-addition technique.

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Optimization of an HPLC Method for Determination of Gabapentin in Dosage Forms through Derivatization with 1-Fluoro-2,4-dinitrobenzene

Cited by 29 publications

References 22 publications

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

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

Sensitive Spectrofluorimetric Method of Analysis for Gabapentin in Pure and Pharmaceutical Preparations

Non-aqueous titrimetric assay of gabapentin in capsules using perchloric acid as titrant

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