Development and Validation of a Simple and Rapid UPLC–MS Assay for Valproic Acid and Its Comparison With Immunoassay and HPLC Methods

Zhao, Mingming; Li, Guofei; Qiu, Feng; Sun, Yingxian; Xu, Yujuan; Zhao, Limei

doi:10.1097/ftd.0000000000000256

Cited by 20 publications

(18 citation statements)

References 17 publications

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“…Therefore, there may be need of sensitive bioanalytical methods to quantify plasma concentrations of valproic acid from a therapeutic drug monitoring perspective. Numerous assays utilizing high performance liquid chromatography (HPLC) coupled with UV, HPLC and ultra-performance liquid chromatography (UPLC) coupled with mass spectrometer and radioimmunoassay's have been developed and validated for the determination of valproic acid in human matrices such as plasma, saliva or dried blood spots [16][17][18][19][20]. The highest sensitivity for the quantitation of valproic acid in human plasma achieved was either 0.1-0.2 µg/mL in some of the assays.…”

Section: Abstract ▼mentioning

confidence: 99%

A Sensitive Triple Quadrupole Liquid Chromatography Mass Spectrometric Method for the Estimation of Valproic Acid in K2EDTA Human Plasma using Furosemide as the Internal Standard

Soni¹,

Patel²,

Singh³

et al. 2016

Drug Res (Stuttg)

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A valproic acid is primarily being used in the treatment of epilepsy is a histone deacetylase inhibitor and it is under investigation for treatment of HIV and various cancer indications. A specific, sensitive and fast bioanalytical LC-MS/MS method was developed with furosemide as an internal standard (IS) and thoroughly validated for the quantitation of valproic acid using turbo ion spray in negative ion mode. The analyte and IS was extracted using protein precipitation. The chromatographic separation of analytes from extracted matrix was achieved using a Chromolith RP 18e (2.0×50 mm) column with a gradient mobile phase comprising of acetonitrile and purified water with acetic acid. The elution of both peaks was achieved within 5.2 min, with retention times of 2.55 min and 1.67 min for valproic acid and IS, respectively. Quantitation of valproic acid was achieved by the pseudo SRM transition pairs ( 142.8→ 142.8), and SRM transition pair ( 328.8 → 204.6) for internal standard.The calibration standards of valproic acid showed linear over a range from 50 to 40 000 ng/mL, with a lower limit of quantitation of 50 ng/mL with accuracy of 3.74% and precision of 5.06%. The bias for inter- and intra-batch assays was 1.24-6.14% and 3.85-11.84%, respectively; while the corresponding precision was 2.56-16.37% and 1.29-11.34%, respectively. The developed method was used to monitor valproic acid levels in clinical samples. Because of higher sensitivity, this method can be used for therapeutic drug monitoring in pediatric subjects.

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Section: Abstract ▼mentioning

confidence: 99%

A Sensitive Triple Quadrupole Liquid Chromatography Mass Spectrometric Method for the Estimation of Valproic Acid in K2EDTA Human Plasma using Furosemide as the Internal Standard

Soni¹,

Patel²,

Singh³

et al. 2016

Drug Res (Stuttg)

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“…5 Monitoring of blood VPA content is often accomplished by using high-performance liquid chromatography (HPLC). 6 In addition, further investigation of VPAinduced early undetected liver impairment is needed. In biology, fibroblast growth factors are a family of multifunctional proteins regulating cell growth, morphogenesis, and endocrine metabolism.…”

Section: Funding Informationmentioning

confidence: 99%

“…However, it can be up to 150–1,500 μg/ml when acute intoxication . Monitoring of blood VPA content is often accomplished by using high‐performance liquid chromatography (HPLC) . In addition, further investigation of VPA‐induced early undetected liver impairment is needed.…”

Section: Introductionmentioning

confidence: 99%

Potential biomarker of fibroblast growth factor 21 in valproic acid‐treated livers

Guo

Liang

et al. 2019

BioFactors

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Background Valproic acid (VPA) is a clinical medicine primarily prescribed to control epileptic symptoms. VPA has potential side‐effects, such as hepatotoxicity. Fibroblast growth factor 21 (FGF21) is a functional cytokine for metabolic regulation. In this article, we aimed to evaluate the possible clinical application of FGF21 in VPA‐treated livers in early undetected liver injury (EULI). Methods Methodologically, plasma samples of VPA‐treated epileptic patients were isolated for biochemical and high‐performance liquid chromatography tests. In addition, VPA‐dosed mice were subjected to determinations of serological parameters, key regulatory effectors and FGF21 expressions through biochemical analyses, enzyme‐linked immunosorbent assay, immunohistochemistry stain, immunofluorescence stain, and reverse transcription‐polymerase chain reaction (RT‐PCR) test, respectively. Results The serological data suggested that VPA‐treated epileptic patients showed visibly elevated FGF21 contents in plasma samples. However, other diagnostic parameters showed inconspicuous changes. As revealed in animal study, VPA‐dosed mice exhibited undetected morphological alterations and hormonal changes in the liver, pancreas, and kidneys. Furthermore, serological parameters and key regulatory proteins in VPA‐dosed livers and controls showed inconspicuous changes. Interestingly, endogenous FGF21 expressions in VPA‐dosed mice were increased in sera. In further experiments, the findings showed that intracellular expressions of FGF21 mRNA and protein were upregulated in VPA‐dosed livers as revealed in RT‐PCR and immunoassay. Conclusions Taken together, these preliminary data reveal that functional FGF21 cytokine may serve as a potent predictor in VPA‐related EULI.

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“…In the relevant consensus guidelines, the effective therapeutic concentration of VPA ranges from 50 to 100 μg/ml and the laboratory alert value is 120 μg/ml (Hiemke et al, 2018). The individual medication of VPA during treatment can improve the control rate of epilepsy and reduce adverse reactions (Gerstner, Bell, & Konig, 2008;Yukawa, 1996).To date, several methods for the quantification of VPA concentrations in biological fluids have been developed, such as immunoassay (Cooreman et al, 2008), liquid chromatography-mass spectrometry (LC-MS) (Gao et al, 2011;Zhao et al, 2016), high-performance liquid chromatography (HPLC) (Mao, Zhao, Sun, Lu, & Li, 2019) and gas chromatography (GC) (Shahdousti, Mohammadi, & Alizadeh, 2007). Among these methods, immunoassay is the most commonly used method in clinical laboratories, while lacking selectivity.…”

Section: Introductionmentioning

confidence: 99%

A novel and nonderivatization method for the determination of valproic acid in human serum by two‐dimensional liquid chromatography

Liu

Shang

Yao

et al. 2019

Biomedical Chromatography

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A novel and robust two‐dimensional liquid chromatography with ultraviolet detection method (2D‐LC–UV) was developed and validated for high‐throughput determination of the concentrations of valproic acid (VPA) in human plasma. This 2D‐LC system was composed of a first‐dimensional LC column, a second‐dimensional LC column and an intermediate transfer column. The sample was directly injected into the 2D‐LC system after an easy protein precipitation treatment. After online preconcentration and primary separation by the first‐dimensional column, the target was captured by an intermediate column and then transferred to second‐dimensional column for analysis. The system transferred the target through “central cutting” mode whereby the drug peak was not subject to interference from the matrix. The analysis cycle time was completed within 7.0 min. Compared with other methods that have been developed, the analysis time was reduced and the operation was much easier without any derivatization. The calibration curve was linear over the 5.90–188.94 μg/ml range for the VPA concentrations. The intra‐day and inter‐day precisions were <5.6%. The recoveries were in the range from 95.2 to 98.0%. This method appears to be sensitive, precise, rapid and low‐cost for the quantification of VPA in serum sample.

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Development and Validation of a Simple and Rapid UPLC–MS Assay for Valproic Acid and Its Comparison With Immunoassay and HPLC Methods

Cited by 20 publications

References 17 publications

A Sensitive Triple Quadrupole Liquid Chromatography Mass Spectrometric Method for the Estimation of Valproic Acid in K2EDTA Human Plasma using Furosemide as the Internal Standard

A Sensitive Triple Quadrupole Liquid Chromatography Mass Spectrometric Method for the Estimation of Valproic Acid in K2EDTA Human Plasma using Furosemide as the Internal Standard

Potential biomarker of fibroblast growth factor 21 in valproic acid‐treated livers

A novel and nonderivatization method for the determination of valproic acid in human serum by two‐dimensional liquid chromatography

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