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 sus-tained 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.

Development and validation of automated SPE‐LC‐MS/MS method for determination of indapamide in human whole blood and its application to real study samples

“…, while the mean values (±SD) of the major pharmacokinetic parameters of indapamide derived from these profiles in Table . The pharmacokinetic parameters calculated here were in line with the literature data (MHRA, ; Schiavi et al ., ; Robinson and Wellington, ; Zhao et al ., ).…”

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

“…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).…”