Determination of amlodipine in human plasma using automated online solid-phase extraction HPLC–tandem mass spectrometry: Application to a bioequivalence study of Chinese volunteers

Shentu, Jianzhong; Li-zhi, FU; Zhou, Haiyan; Hu, Xing; Liu, Jian; Chen, Junchun; Wu, Guolan

doi:10.1016/j.jpba.2012.06.014

Cited by 31 publications

(20 citation statements)

References 8 publications

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“…Concentration of levamlodipine in human plasma showed good linear relationship within 0.05 ~ 10 µg × L − 1 . The relative standard deviation (RSD) values of intra-and interday precision were both less than 10%; and endogenous substances do not interfere with the determination of levamlodipine [9]. C max , AUC 0 − t and AUC 0−∞ were transformed by logarithm and analyzed by variance.…”

Section: Discussionmentioning

confidence: 99%

“…Data collection and handling was employed with Analyst 1.6.3 software (Applied Biosystems, Foster City, CA, U.S.A.). The solid-phase extraction (SPE) experiments [9] were performed by HLB 96-well Plate (Waters Oasis, WAT058951). The plate contains a reversed phase functionalized polymeric sorbent (30 mg/well), in which particle size is 30 μm.…”

Section: Bioanalysismentioning

confidence: 99%

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Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: A single-dose and two-period crossover randomized study

Wang

et al. 2020

Preprint

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Background: Levamlodipine, a calcium channel blocker, is used in treatment of hypertension. To compare the pharmacokinetic parameters between levamlodipine test formulation at a single dose of 5 mg and amlodipine reference formulation at a single dose of 10 mg, the bioequivalence study was carried out.Methods: A single-dose randomized, open-label, two-period crossover study was designed in healthy Chinese subjects. 48 subjects were divided into fasting and high-fat meal group equally. The subjects randomly received the test or reference formulations at the rate of 1:1. Following a 21-day washout period, the alternative formulations were received. The blood samples were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours later. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was applied to determine levamlodipine in the plasma samples.Results: Within equivalence limits between 80 ~ 125%, the test formulation and the reference formulation were bioequivalent, with the 90% confidence intervals (CIs) for the ratio of geometric means of Cmax, AUC0-t, and AUC0-∞. The data were shown as Cmax (89.59% ~ 101.61%), AUC0-t (87.83% ~ 94.87%) and AUC0-∞ (86.28% ~ 93.49%) under fasting condition, Cmax (90.93% ~ 102.37%), AUC0–t (95.75% ~ 104.93%) and AUC0–∞ (95.36% ~ 105.33%) under high-fat meal condition. Serious adverse event was not observed.Conclusions: The trial confirmed that levamlodipine at a single dose of 5 mg and amlodipine at a single dose of 10 mg were bioequivalent under both fasting condition and high-fat meal condition.Trial registration: Cinicaltrials, NCT04411875. Registered 3 June 2020 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009W1Q&selectaction=Edit&uid=U00050YQ&ts=3&cx=-6iqkm8

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Section: Discussionmentioning

confidence: 99%

Section: Bioanalysismentioning

confidence: 99%

Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: A single-dose and two-period crossover randomized study

Wang

et al. 2020

Preprint

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“…According to Shentu et al. , method recovery was evaluated by comparing the peak area of QC samples to standards in water ( n = 3).…”

Section: Methodsmentioning

confidence: 99%

“…The sample pretreatment methods were complicated and time consuming, and only tested diazepam and its free metabolites: nordazepam, oxazepam, and temazepam. Recently, online SPE technology has received an increasing amount of attention by analysts and widely applied to forensic toxicological analysis . Online SPE not only overcomes the shortcoming of offline SPE, but also avoids human errors.…”

Section: Introductionmentioning

confidence: 99%

Sensitive, automatic method for the determination of diazepam and its five metabolites in human oral fluid by online solid‐phase extraction and liquid chromatography with tandem mass spectrometry

Jiang

Rao

Wang

et al. 2016

J of Separation Science

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A novel and simple online solid-phase extraction liquid chromatography-tandem mass spectrometry method was developed and validated for the simultaneous determination of diazepam and its five metabolites including nordazepam, oxazepam, temazepam, oxazepam glucuronide, and temazepam glucuronide in human oral fluid. Human oral fluid was obtained using the Salivette(®) collection device, and 100 μL of oral fluid samples were loaded onto HySphere Resin GP cartridge for extraction. Analytes were separated on a Waters Xterra C18 column and quantified by liquid chromatography with tandem mass spectrometry using the multiple reaction monitoring mode. The whole procedure was automatic, and the total run time was 21 min. The limit of detection was in the range of 0.05-0.1 ng/mL for all analytes. The linearity ranged from 0.25 to 250 ng/mL for oxazepam, and 0.1 to 100 ng/mL for the other five analytes. Intraday and interday precision for all analytes was 0.6-12.8 and 1.0-9.2%, respectively. Accuracy ranged from 95.6 to 114.7%. Method recoveries were in the range of 65.1-80.8%. This method was fully automated, simple, and sensitive. Authentic oral fluid samples collected from two volunteers after consuming a single oral dose of 10 mg diazepam were analyzed to demonstrate the applicability of this method.

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“…Several methods are available in the literature to measure the concentration of VS and AM in individual and combined products (21)(22)(23). The method was validated for parameters like system suitability, selectivity, linearity, range, precision, accuracy, and robustness.…”

Section: Methods Validationmentioning

confidence: 99%

Development of a Dissolution Method to Compare Tablet Formulations Containing Valsartan/Amlodipine

Zaid¹,

Qaddomi²,

Ghanem³

et al. 2015

Dissolution Technol.

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Dissolution profiles were developed in three different pH media for the evaluation of valsartan/amlodipine (VS/AM) release from tablets. The selection of the most appropriate dissolution method was based on the calculated similarity (f 2 ) and dissimilarity (f 1 ) values. A new HPLC method was developed to quantify VS/AM in tablets. The method was validated in accordance with international guidelines and showed acceptable linearity, accuracy, precision, and selectivity. The system suitability results are within the acceptance criteria. The dissolution method (pH 6.8 phosphate buffer) was selected because it showed the highest f 2 and the lowest f 1 values for VS and AM among the other tested dissolution media. This method could be used for in vitro quality control and for performing in vitro-in vivo correlation (IVIVC) during the development of new generic tablets.

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Determination of amlodipine in human plasma using automated online solid-phase extraction HPLC–tandem mass spectrometry: Application to a bioequivalence study of Chinese volunteers

Cited by 31 publications

References 8 publications

Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: A single-dose and two-period crossover randomized study

Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: A single-dose and two-period crossover randomized study

Sensitive, automatic method for the determination of diazepam and its five metabolites in human oral fluid by online solid‐phase extraction and liquid chromatography with tandem mass spectrometry

Development of a Dissolution Method to Compare Tablet Formulations Containing Valsartan/Amlodipine

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