Liquid chromatography–tandem mass spectrometry validated method for the estimation of indapamide in human whole blood

Jain, Deepak S.; Subbaiah, Gunta; Sanyal, Mallika; Pande, U. C.; Shrivastav, Pranav S.

doi:10.1016/j.jchromb.2006.02.040

Cited by 24 publications

(29 citation statements)

References 16 publications

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“…LC-MS methods for the quantitation of indapamide in blood have been reported frequently in recent years [6][7][8][9][10]. The LC-MS method has high specificity and sensitivity, since the limit of quantification of indapamide was found to be 0.5-2 ng/ml in these reports.…”

Section: Introductionmentioning

confidence: 99%

Determination of indapamide in human serum using 96-well solid-phase extraction and high-performance liquid chromatography–tandem mass spectrometry (LC–MS/MS)

Morihisa

Fukata

Muro

et al. 2008

Journal of Chromatography B

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Section: Introductionmentioning

confidence: 99%

Determination of indapamide in human serum using 96-well solid-phase extraction and high-performance liquid chromatography–tandem mass spectrometry (LC–MS/MS)

Morihisa

Fukata

Muro

et al. 2008

Journal of Chromatography B

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“…IP, BP, and USP describe HPLC method for its estimation. Literature survey reveals LC-MS 15 , spectrophotometric 16 This combination is not official in any pharmacopoeia hence official and reported methods of analysis are not available for this combination. The present manuscript describes simple, sensitive, accurate, precise, rapid and economic First derivative spectrophotometric method for simultaneous estimation of AMLO and INDA in tablet dosage form.…”

Section: Introduction: Amlodipine Besylate (Amlo) Is Chemically 3-ethmentioning

confidence: 99%

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2012

IJPSR

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A simple, specific, accurate and precise reversed phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Amlodipine Besyltate and Indapamide in tablet dosage form by reversed phase C 18 column (Phenomenex C 18 , 5μ, 250 mm x 4.6 mm). The sample was analysed using Methanol: Water in the ratio of 95:5 as a mobile phase at a flow rate of 1.0 ml/min and detection at 238 nm. Calibration curves were linear with correlation coefficient (r 2 ) 0.996 over a concentration range of 2-16 µg/mL for Amlodipine besylate and 0.997 over a concentration range of 1-7 µg/mL for Indapamide. The retention time for Amlodipine besylate and Indapamide was found to be 8.722 and 2.855 min respectively. The mean recoveries were found to be 99.98 ± 1.40 and 100.37 ± 1.25 %. for Amlodipine besylate and Indapamide respectively. The relative standard deviation (RSD) was found to be <2.0 % for both drugs. The proposed method was validated and successfully applied to the estimation of Amlodipine besylate and Indapamide in tablet dosage form.

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“…In contrast, HPLC-UV methods [ 9 , 18 ] , giving a higher LLOQ of 10 ng/mL, are not suitable for pharmacokinetics study of indapamide in plasma. Florin Albu [ 16 ] and Deepak S. Jain [ 19 ] reported HPLC-MS/MS methods with LLOQ of 1 ng/mL and 0.5 ng/mL respectively, but they adopted a superior instrument (HPLC-MS/MS), which is more expensive than HPLC-MS. Consequently, HPLC-MS is economic and suitable for pharmacokinetics study of indapamide. The results from the ANOVA found that formulation, period, and sequence had no statistically signifi cant eff ect on AUC 0-τ , AUC 0-∞ and C max at the signifi cance level of 0.05.…”

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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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Liquid chromatography–tandem mass spectrometry validated method for the estimation of indapamide in human whole blood

Cited by 24 publications

References 16 publications

Determination of indapamide in human serum using 96-well solid-phase extraction and high-performance liquid chromatography–tandem mass spectrometry (LC–MS/MS)

Determination of indapamide in human serum using 96-well solid-phase extraction and high-performance liquid chromatography–tandem mass spectrometry (LC–MS/MS)

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

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