Validated HPLC Method for Quantification of Pregabalin in Human Plasma Using 1-Fluoro-2,4-dinitrobenzene as Derivatization Agent

Ahmadkhaniha, Reza; Mottaghi, Siavash; Zargarpoor, Mohammad; Souri, Effat

doi:10.1155/2014/450461

Cited by 9 publications

(4 citation statements)

References 21 publications

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“…FDNB was used for analysis (UV-visible spectrophotometer) of pregabalin only as the drug (pregabalin) does not contain any chromophore group. FDNB is a common reagent used for analysis of amino acids or compounds containing free amine group 30 .…”

Section: Tablet Batchesmentioning

confidence: 99%

Preparation and evaluation of floating tablets of pregabalin

Kanwar

Kumar

Sarwal

et al. 2015

Drug Development and Industrial Pharmacy

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Floating tablets of pregabalin were prepared using different concentrations of the gums (xanthan gum and guar gum), Carbopol 974P NF and HPMC K100. Optimized formulations were studied for physical tests, floating time, swelling behavior, in vitro release studies and stability studies. In vitro drug release was higher for tablet batches containing guar and xanthan gum as compared to the batches containing Carbopol 974P NF. Tablet batches were subjected to stability studies and evaluated by different parameters (drug release, drug content, FTIR and DSC studies). The optimized tablet batch was selected for in vivo pharmacodynamic studies (PTZ induced seizures). The results obtained showed that the onset of jerks and clonus were delayed and extensor phase was abolished with time in treated groups. A significant difference (p > 0.05) was observed in control and treated group behavior indicating an excellent activity of the formulation for a longer period (>12 h).

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Section: Tablet Batchesmentioning

confidence: 99%

Preparation and evaluation of floating tablets of pregabalin

Kanwar

Kumar

Sarwal

et al. 2015

Drug Development and Industrial Pharmacy

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“…The European Federation of Neurological Societies recommendations are using PGB as a first-line treatment for management of pain with patients suffering post-herpetic neuralgia, central neuropathic pain, and painful diabetic neuropathy [24]. There are few reported analytical methods for assay of PGB in biological fluids and pharmaceuticals involving GC-MS [25,26], LC-MS [27][28][29], HPLC [30][31][32][33], spectrophotometry [34] and TLC [35,36]. After oral intake, PGB is rapidly absorbed with high bioavailability of more than 90% [37].…”

Section: Introductionmentioning

confidence: 99%

“…There are few reported methods for analysis of PGB in human plasma or human urine by HPLC after precolumn derivatization using different derivatizing agents [30][31][32]. In practice, derivatization is considered a tedious technique which requires extra steps and strictly maintained conditions to obtain accurate estimation of the analyte [27].…”

Section: Introductionmentioning

confidence: 99%

ESI–LC–MS/MS for Therapeutic Drug Monitoring of Binary Mixture of Pregabalin and Tramadol: Human Plasma and Urine Applications

Almalki

Ali²,

Elroby

et al. 2021

Separations

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Tramadol (TRM) and pregabalin (PGB) are frequently used in combination for neuropathic pain management. Accordingly, a selective and sensitive high-performance liquid chromatography–electrospray ionization–mass/mass spectrometric (ESI–LC–MS/MS) method is presented for determination of TRM and PGB, whether in pure forms or human biological fluids (plasma/urine), using gabapentin (GBP) (IS) as the internal standard. Chromatographic separation was effected in total run time of 2.5 min, on Phenomenex Luna® Omega 1.6 um polar C18 (LC 150 × 2.1 mm) column with a mobile phase of methanol/water (70:30, v/v), 0.1% (v/v) formic acid at a flow rate of 0.3 mL/min. Ionization of the analytes was obtained using electrospray in the positive ion mode (ESI+). The MS/MS detection was performed by monitoring the fragments for TRM, PGB and GBP on a triple quadrupole mass spectrometer. Assay calibration was over the range of 10–1000 ng mL−1 for TRM and PGB with the correlation coefficients over 0.999 in pure form, human plasma and urine spiked with the studied compounds. Validation data showed the inter-run relative standard deviations (RSDs) were less than 4.3% for TRM and 3.8% for PGB, whereas the intra-run RSDs were less than 3.7% for TRM and 3.6% for PGB. The mean extraction recoveries for TRM and PGB were in the ranges of 86.51%–93.38% and 86.20%–92.42%. This method was successfully performed on real plasma and urine samples taken from neuropathic patients and proved to be an applicable method for routine therapeutic drug monitoring of the proposed drug combination.

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“…Bali & Gaur (2011) developed another spectrophotometric method for the determination of PGB in pure and pharmaceutical forms through complexing of PGB with ninhydrin (NIN) reagent (Bali & Gaur, 2011). Other analytical methods were published for analysis of PGB in pure and commercial forms and also in biological fluids, including high‐performance thin layer chromatography (HPTLC) methods (Prasad, Sagar, & Sudhakar, 2013; Shah, Patelia, & Mori, 2013), HPLC (Ahmadkhaniha, Mottaghi, Zargarpoor, & Souri, 2014; Bhatt, Emanual, & Aswin, 2013; Douša, Gibala, & Lemr, 2010; Martinc, Roškar, Grabnar, & Vovk, 2014; Vermeij & Edelbroek, 2004), LC–MS/MS (Chahbouni et al, 2013; Dżygiel & Fraier, 2011; Mandal et al, 2008) and GC–MS (Mudiam et al, 2012; Sowjanya, Thejaswini, Gurupadayya, & Raja, 2011).…”

Section: Introductionmentioning

confidence: 99%

Ecologically evaluated and FDA‐validated HPTLC method for assay of pregabalin and tramadol in human biological fluids

Naguib

Ali²,

Elroby

et al. 2020

Biomedical Chromatography

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The introduced research presents a novel in vivo quantitative method for assay of mixtures of pregabalin and tramadol as a common combinations approved for treatment of neuropathic pain. Green analytical chemistry is a recently emerging science concerned with control of the use of chemicals harmful to the environment in various analytical methods. Consequently, a green high‐performance thin layer chromatography (HPTLC) method was achieved for determination of the mixture in human plasma and urine satisfying both analytical and environmental standards. The separation was achieved on HPTLC sheets using a separating mixture of ethanol–ethyl acetate–acetone–ammonia solution (8:2:1:0.05, by volume) as a mobile phase. The sheets were dried in air then scanned at two wavelengths. For tramadol, 220 nm was chosen; however, pregabalin is an unconjugated drug, so its determination was a challenge. Hence for pregabalin, the plates were sprayed with ethanolic solution of ninhydrin (3%, w/v), to obtain a conjugated complex, which could be assessed at 550 nm. Furthermore, the developed method fulfilled the US Food and Drug Administration validation guidelines, and proved to be useful in therapeutic drug monitoring of this combination. The Eco‐scale assessment protocol was implemented to determine the greenness profile of the applied method.

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Validated HPLC Method for Quantification of Pregabalin in Human Plasma Using 1-Fluoro-2,4-dinitrobenzene as Derivatization Agent

Cited by 9 publications

References 21 publications

Preparation and evaluation of floating tablets of pregabalin

Preparation and evaluation of floating tablets of pregabalin

ESI–LC–MS/MS for Therapeutic Drug Monitoring of Binary Mixture of Pregabalin and Tramadol: Human Plasma and Urine Applications

Ecologically evaluated and FDA‐validated HPTLC method for assay of pregabalin and tramadol in human biological fluids

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