Liquid chromatography-electrospray tandem mass spectrometry method for determination of indapamide in serum for single/multiple dose bioequivalence studies of sustained release formulations.
Indapamide and internal standard (5-chloro-2-methoxy-N-[2-(4-sulphamoylphenyl)ethyl]benzamide) were isolated from plasma by a single step liquid-liquid extraction in t-butyl methyl ether. The chromatographic separation was achieved on a reversed-phase C(18) monolithic column with a mobile phase consisting in a methanol/aqueous 0.1% formic acid mixture and a flow rate of 0.8 ml/min, in isocratic conditions, within 11 min. Target compounds were transferred in an ion trap analyzer via an atmospheric pressure electrospray interface (AP-ESI). The mass analyzer was used in a selected reaction monitoring (SRM) mode, in order to enhance on detection selectivity. Whole method produces quantitation limit for indapamide of 1 ng/ml. Method was successfully applied to assess bioequivalence of two sustained release marketed pharmaceutical formulations of indapamide 1.5 mg coated tablets, carried-out in a single/multiple doses, randomized design.
Albu
Florin
F
LaborMed Pharma, Splaiul Independentei no. 319, Bucharest (6)-060044, Romania.
Georgiţă
Cristina
C
David
Victor
V
Medvedovici
Andrei
A
D000959:Antihypertensive Agents / Q000097:blood* / Q000493:pharmacokinetics*; D003692:Delayed-Action Preparations / Q000032:analysis; D004355:Drug Stability; D007190:Indapamide / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013810:Therapeutic Equivalency
D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D007190:Indapamide