Simple, sensitive and rapid LC–MS method for the quantitation of indapamide in human plasma—application to pharmacokinetic studies

CHEN, W

doi:10.1016/j.jchromb.2006.03.024

Cited by 22 publications

(22 citation statements)

References 10 publications

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“…Previous studies describing indapamide quantitation in biological matrices have presented total run times from 8 to 15 min (Albu et al ., ; Chen et al ., ; Ding et al ., ; Hang et al ., ; Morihisa et al ., ; Li et al ., ). In addition, for indapamide determination in whole blood, Tang et al .…”

Section: Resultsmentioning

confidence: 99%

“…Previous studies describing indapamide quantitation in biological matrices have presented total run times from 8 to 15 min (Albu et al, 2005;Chen et al, 2006;Ding et al, 2006;Hang et al, 2006;Morihisa et al, 2008;Li et al, 2013). In addition, for indapamide determination in whole blood, Tang et al (2005) and Hang et al (2006) achieved lower limits of quantitation of 2 and 10 ng/mL, respectively.…”

Section: Lc-ms/ms Methodsmentioning

confidence: 99%

“…Binding to plasma proteins is approximately 76% (Caruso et al, 1983;Robinson and Wellington, 2006). Some methods have been reported for the quantitation of indapamide in biological matrices, such as plasma (Chen et al, 2006;Ding et al, 2006;Li et al, 2013), serum (Albu et al, 2005;Morihisa et al, 2008) or whole blood (Tang et al, 2005;Hang et al, 2006;Zhao et al, 2010), using high-performance liquid chromatography (HPLC). Most of these methods used HPLC coupled to a mass spectrometer, since mass spectrometric detection is suitable for the quantitative analysis of a variety of drugs in many biological matrices (Hopfgartner and Bourgogne, 2003).…”

Section: Introductionmentioning

confidence: 99%

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An improved LC‐MS/MS method for quantitation of indapamide in whole blood: application for a bioequivalence study

Pinto

Pastre²,

Bellorio

et al. 2014

Biomedical Chromatography

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An improved LC-MS/MS method for the quantitation of indapamide in human whole blood was developed and validated. Indapamide-d3 was used as internal standard (IS) and liquid-liquid extraction was employed for sample preparation. LC separation was performed on Synergi Polar RP-column (50 × 4.6 mm i.d.; 4 µm) and mobile phase composed of methanol and 5 mm aqueous ammonium acetate containing 1 mm formic acid (60:40), at flow rate of 1 mL/min. The run time was 3.0 min and the injection volume was 20 μL. Mass spectrometric detection was performed using electrospray ion source in negative ionization mode, using the transitions m/z 364.0 → m/z 188.9 and m/z 367.0 → m/z 188.9 for indapamide and IS, respectively. Calibration curve was constructed over the range 0.25-50 ng/mL. The method was precise and accurate, and provided recovery rates >80% for indapamide and IS. The method was applied to determine blood concentrations of indapamide in a bioequivalence study with two sustained release tablet formulations. The 90% confidence interval for the geometric mean ratios for maximum concentration was 95.78% and for the area under the concentration-time curve it was 97.91%. The tested indapamide tablets (Eurofarma Laboratórios S.A.) were bioequivalent to Natrilix®, according to the rate and extent of absorption.

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Section: Resultsmentioning

confidence: 99%

Section: Lc-ms/ms Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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An improved LC‐MS/MS method for quantitation of indapamide in whole blood: application for a bioequivalence study

Pinto

Pastre²,

Bellorio

et al. 2014

Biomedical Chromatography

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“…Indapamide is extensively metabolised, with only about 7 % of the total dose administered recovered in the urine as unchanged drug during the fi rst 48 h after administration [ 10 , 11 ] . Although Li Ding et al [ 12 ] , Wei-Dong Chen et al [ 13 ] and Tai-Jun Hang et al [ 9 ] have researched the pharmacokinetics and bioavailability of indapamid in the Chinese population, they focus on the method for the quantitation of indapamide in vivo, which is simple, sensitive and rapid. The information concerning the bioavailability and pharmacokinetics of indapamide in the Chinese population has not been reported in detail up to now.…”

Section: Pharmacokinetics and Bioequivalence Study Of Two Indapamide mentioning

confidence: 99%

Pharmacokinetics and Bioequivalence Study of Two Indapamide Formulations after Single-dose Administration in Healthy Chinese Male Volunteers

Zhang

Tian

et al. 2012

Drug Res

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The pharmacokinetics and relative bioavailability/bioequivalence of 2 formulations of indapamide were assessed in this paper. The study was conducted in 20 healthy Chinese male volunteers according to an open, randomized, single-blind, 2-way crossover study design with a wash-out phase of 7 days. Blood samples for pharmacokinetic profiling were taken up to 84 h post-dose, and indapamide concentrations in plasma were determined by a validated liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS) method. Based on the plasma concentration-time data of each individual in each period, pharmacokinetic parameters, Cmax, AUC0-τ, AUC0-∞ and t1/2, were calculated by non-compartmental analysis. Pharmacokinetic parameters for test and reference formulations were analyzed statistically to assess bioequivalence of the 2 formulations. The values of Cmax, Tmax, t1/2, AUC0-τ, AUC0-∞ for test and reference formulations were 49.53±5.53 and 47.79±4.68 ng/mL, 1.9±0.6 and 2.0±0.5 h, 22.49±5.93 and 23.23±4.48 h, 859.51±160.92 and 840.90±170.62 ng · h/mL, 934.35±190.60 and 919.52±179.74 ng · h/mL, respectively. The 90% confidence intervals of the T/R-ratios of logarithmically transformed data were within the accepted range of 80-125%. It showed that the 2 formulations of indapamide were bioequivalent. Both preparations were well tolerated and no adverse reactions were found throughout the study.

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“…Nakov, K. Mladenovska, D. Zafirov, A. Dimovski, R. Petkovska, A. Dimitrovska, Z. Kavrakovski amide in serum under isocratic conditions, within 11min and 5min, respectively. Another published LC-MS method (Chen et al, 2006) employs LLE and gradient elution with a runtime of 7.5 min. LC-MS/MS method using automated 96-well SPE for determination of indapamide in human serum was described by Morihisa et al (2008).…”

Section: Introductionmentioning

confidence: 99%

High-throughput SPE-LC-MS/MS method for determination of indapamide in human serum

Nakov¹,

Mladenovska²,

Zafirov³

et al. 2013

Maced. Pharm. Bull.

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Simple, automated SPE procedure combined with fast LC-MS/MS chromatographic separation resulted in obtaining high-throughput LC-MS/MS method for determination of indapamide in serum. The SPE procedure was performed on polymeric mixed-mode sorbent and the analytes were quantitated using electrospray ionization in positive mode. The recovery of indapamide and internal standard were 89.25- 90.36% and 79.10%, respectively. Experimentally it was confirmed that the matrix effect had a negligible effect of ionization efficiency. The validation data showed that the proposed method provides accurate and reproducible results in range of 0.50-50 ng/mL. In addition, a comparison was made between the method for determination of indapamide in serum and in blood (develop in our previously work) regarding the extraction procedure and matrix effect.

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Simple, sensitive and rapid LC–MS method for the quantitation of indapamide in human plasma—application to pharmacokinetic studies

Cited by 22 publications

References 10 publications

An improved LC‐MS/MS method for quantitation of indapamide in whole blood: application for a bioequivalence study

An improved LC‐MS/MS method for quantitation of indapamide in whole blood: application for a bioequivalence study

Pharmacokinetics and Bioequivalence Study of Two Indapamide Formulations after Single-dose Administration in Healthy Chinese Male Volunteers

High-throughput SPE-LC-MS/MS method for determination of indapamide in human serum

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