Comparison of liquid chromatography-ultraviolet and chromatography-tandem mass spectrometry for the determination of indapamide in human whole blood and their applications in bioequivalence studies

Abstract

The aim of this study was to compare two methods which were based on liquid chromatography with ultraviolet detection (LC-UV) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), respectively, to determine indapamide (CAS 26807-65-8) and to apply them to bioequivalence studies. The universal parameters, including selectivity, linearity, precision, and quantification limit, served as gold standard for the comparison of the two methods. As a result, the two methods were both very consistent and reliable. Furthermore, the LC-MS/MS method required only one-fifth the blood volume needed by the other method and was approximately 25 times more sensitive than the other method. The total run time of the LC-MS/MS method was 3.5 min per sample as opposed to 11 min for the other method. Forty healthy male Chinese volunteers were selected as subjects. One half were orally administrered 2.5 mg indapamide immediate release tablets while the other half were orally administered 1.5 mg indapamide sustained release coated tablets. The collected blood samples were determined with the two methods described above. The pharmacokinetic parameters were determined using a noncompartmental method. For the bioequivalence studies, the pharmacokinetic parameters acquired here were in line with the literature and parameters met the criteria set by the State Food and Drug Administration of China (SFDA) for bioequivalence study, indicating that generic drugs are bioequivalent to branded drugs. The present study suggests that the two methods based on LC-UV and LC-MS/MS were suitable for bioavailability studies of indapamide with different pharmaceutical formulations. Consequently, it can be believed that the criterion that each individual expected concentration range would need a given bioassay with the requested sensitivity is not absolutely right. In practice, most of the time, the highest sensitivity allows to bioassay concentrations in a higher range.

Key words

Bioassay - CAS 26807-65-8 - Diuretic - Indapamide - Tandem mass spectrometry

• References

• 1 Chen D. Determination of indapamide in human serum by high performance liquid chromatography. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 1990; 12 (4) 286-9
• 2 Choi RL, Rosenberg M, Grebow PE, Huntley TE. High-performance liquid chromatographic analysis of indapamide (RHC 2555) in urine, plasma and blood. J Chromatogr. 1982; 230 (1) 181-7
• 3 Gaetani E, Laureri CF, Vitto M, Borghi L, Elia GF, Novarini A. Determination of indapamide in plasma by HPLC. Boll Chim Farm. 1986; 125 (1) 35-7
• 4 Hang TJ, Zhao W, Liu J, Song M, Xie Y, Zhang Z et al A selective HPLC method for the determination of indapamide in human whole blood: application to a bioequivalence study in Chinese volunteers. J Pharm Biomed Anal. 2006; 40 (1) 202-5
• 5 Hutt V, Pabst G, Dilger C, Poli G, Acerbi D. Bioavailability and pharmacokinetics of a fixed combination of delapril/indapamide following single and multiple dosing in healthy volunteers. Eur J Drug Metab Pharmacokinet. 1994; 19 (1) 59-69
• 6 Legorburu MJ, Alonso RM, Jimenez RM, Ortiz E. Quantitative determination of indapamide in pharmaceuticals and urine by high-performance liquid chromatography with amperometric detection. J Chromatogr Sci. 1999; 37 (8) 283-7
• 7 Miller RB, Dadgar D, Lalande M. High-performance liquid chromatographic method for the determination of indapamide in human whole blood. J Chromatogr. 1993; 614 (2) 293-8
• 8 Pietta P, Calatroni A, Rava A. High-performance liquid chromatographic assay for monitoring indapamide and its major metabolite in urine. J Chromatogr. 1982; 228: 377-81
• 9 Zendelovska D, Stafilov T, Stefova M. Optimization of a solid-phase extraction method for determination of indapamide in biological fluids using high-performance liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2003; 788 (1) 199-206
• 10 Ding L, Yang L, Liu F, Ju W, Xiong N. A sensitive LC-ESI-MS method for the determination of indapamide in human plasma: method and clinical applications. J Pharm Biomed Anal. 2006; 42 (2) 213-7
• 11 Song M, Gao X, Hang T, Wen A. Simultaneous determination of lansoprazole and its metabolites 5’-hydroxy lansoprazole and lansoprazole sulphone in human plasma by LC-MS/MS: application to a pharmacokinetic study in healthy volunteers./Pharm Biomed. Anal. 2008; 48 (4) 1181-6
• 12 Chen WD, Liang Y, Zhang H, Li H, Xiong Y, Wang GJ et al Simple, sensitive and rapid LC-MS method for the quantitation of indapamide in human plasma-application to pharmacokinetic studies. J Chromatogr B Analyt Technol Biomed Life Sci. 2006; 842 (1) 58-63
• 13 Morihisa H, Fukata F, Muro H, Nishimura K, Makino T. Determination of indapamide in human serum using 96-well solid-phase extraction and high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). J Chromatogr B Analyt Technol Biomed Life Sci. 2008; 870 (1) 126-30
• 14 Albu F, Georgita C, David V, Medvedovici A. Liquid chroma-tography-electrospray tandem mass spectrometry method for determination of indapamide in serum for single/multiple dose bioequivalence studies of sustained release formulations. J Chromatogr B Analyt Technol Biomed Life Sc. 2005; 816 (1–2) 35-40
• 15 Jain DS, Subbaiah G, Sanyal M, Pande UC, Shrivastav P. Liquid chromatography-tandem mass spectrometry validated method for the estimation of indapamide in human whole blood. J Chromatogr B Analyt Technol Biomed Life Sci. 2006; 834 (1–2) 149-54
• 16 Marzo A, Bo LD. Tandem mass spectrometry (LC-MS/MS): a predominant role in bioassays for pharmacokinetic studies. Arzneimittelforschung. 2007; 57 (2) 122-8