Development and validation of a high‐performance liquid chromatography–tandem mass spectrometric method for simultaneous determination of bupropion, quetiapine and escitalopram in human plasma

Park, Semin; Park, Chul Soo; Lee, Sung‐Joon; Cha, Boseok; Cho, Young Ah; Song, Yi; Yu, Eun Ae; Kim, Gon Sup; Jin, Jong Sung; El‐Aty, A. M. Abd; El-Banna, H. A.; Hacımüftüoğlu, Ahmet; Shin, Sung Chul

doi:10.1002/bmc.3322

Cited by 12 publications

(2 citation statements)

References 30 publications

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“…As reported, there are many ways to quantitatively analyze quetiapine in human biological samples such as HPLC,28 HPLC-MS/MS,29,30 and liquid chromatography (LC)/MS/MS 19,24,31–33. However, method for BE study of 200 mg quetiapine XR in Chinese volunteers was only one; LC-MS/MS technology was used 34.…”

Section: Discussionmentioning

confidence: 99%

Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles

Huang¹,

Zhang

Ma³

et al. 2018

DDDT

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ObjectiveThe objectives of this study were to evaluate the bioequivalence of Quesero extended release (Quesero XR) tablets and Seroquel extended release (Seroquel XR) tablets under fasting and fed conditions and to determine the effect of food on the pharmacokinetic (PK) properties of Quesero XR or Seroquel XR in Chinese healthy volunteers.MethodsA single-site, randomized, open-label, two-period crossover design with a 10-day washout period was conducted in 20 subjects under the fed and fasting studies. A single oral dose of 200 mg Quesero XR or Seroquel XR was given to the subjects after an overnight fast of 10 hours. Blood samples were taken at scheduled time spots from 0 hour pre dose to 36 hours post dose. Plasma concentrations of quetiapine were measured by a validated ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method. The PK parameters were calculated by non-compartment analysis using Phoenix WinNonlin software.ResultsOn both conditions, no significant differences were found among the main PK parameters of the two preparations by analysis of variance (P>0.05); the Wilcoxon test of maximum peak plasma concentration (Tmax) showed no significant differences (P>0.05); the 90% confidence limit (CL) of lnCmax, lnAUC0→36, and lnAUC0→∞ fell within the acceptable range of 80%–125%. As compared with the fasting state, the Tmax was advanced and the mean maximum plasma concentration (Cmax), AUC0→36, and AUC0→∞ were also increased in the fed state; the geometric mean ratio and 90% CI of the main PK parameters fell outside the range of the CIs; analysis of variance showed significant differences in the other PK parameters except for apparent total clearance after oral administration (clearance rate; P<0.05).ConclusionThe two formulations of Quesero XR and Seroquel XR are bioequivalent under both fasting and fed conditions, and food may affect the PK profiles by increasing the rate and extent of absorption of Quesero XR or Seroquel XR in Chinese healthy volunteers.

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Section: Discussionmentioning

confidence: 99%

Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles

Huang¹,

Zhang

Ma³

et al. 2018

DDDT

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“…Reported C max based on Bupropion hydrochloride 100 mg tablets for BPR, HBPR and THBPR are 136.2 ng/ml, 269.0 ng/ml and 88.8 ng/ml, respectively. Literature reveals that HPLC methods for plasma, [1][2][3][4] stability method for plasma, 5 metabolite characterization, [6][7] LC-MS methods for human plasma [8][9][10][11][12][13] and rat plasma, 14 pharmacokinetics analysis in human or rat plasma [15][16][17][18][19][20][21][22][23][24] for bupropion and/its metabolite(s) and LC-MS methods for bupropion with combination [25][26][27] are reported. It is noted that reported HPLC methods are not sensitive for the quantification in terminal plasma concentration of bupropion and/or metabolites.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Quantitative Determination of Bupropion and its Metabolites by High Performance Liquid Chromatography Tandem Mass Spectrometry Detection: Application to Bioequivalence Study

Shahi¹,

Patel²,

Shah³

et al. 2018

IJPER

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Objective: A rapid, selective, sensitive, precise and accurate liquid chromatography in tandem with electro-spray ionization mass spectrometry method has been developed and validated for the simultaneous quantification of bupropion (BPR), hydroxyl bupropion (HBPR), erythrohydrobupropion (EHBPR) and threohydrobupropion (THBPR) in human plasma using only 100µL of human plasma sample. Methodology: Multi reaction monitoring detection was performed by electrospray ionization in the positive ion mode, conferring an additional selectivity to the method. The solid phase extraction technique was used for sample preparation. Chromatographic separation of drug and metabolites with better peak shape and resolution was achieved by using an Acquity BEH phenyl column with an isocratic elution of 42 % methanol and 58 % ammonia (0.06%, v/v) aqueous solution at a flow rate of 0.5 ml/min. Methanol was chosen because it enabled good resolution between THBPR and EHBPR as well as good peak symmetry of all the four analytes. Detection was carried out by mass spectrometry using positive electro-spray ionization mode, and the compounds were monitored using multiple reactions monitoring method. Deuterium-labeled isotopes of the compounds were used as internal standards. Results and Conclusion: No significant matrix effect was observed in the presented method. The assay method was validated over the concentration range of 1.75-500 ng/ml for BPR; 5-1000 ng/ml for HBPR; 0.5-100 ng/ml for EHBPR; and 2-500 ng/ml for THBPR as per FDA guideline and validated method was successfully applied for estimation of drug and metabolite concentration in the healthy adult volunteers, bioequivalence and pharmacokinetic study of Bupropion hydrochloride 300 mg extended release tablets under fasting condition.

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