ABSTRACT
Simple and sensitive methods were developed for the determination of indapamide, perindopril and its active metabolite perindoprilat in human plasma or whole blood by hyphenated ultra-performance li-quid chromatography-mass spectrometry (UPLC-MS/MS). Indapamide-d3, perindopril-d4 and perindo-prilat-d4 were used as the internal standards. The separation was performed on a Thermo BDS Hypersil C18column (4.6 mm × 100 mm, 2.4 μm) for indapamide and perindopril simultaneously following a protein precipitation pretreatment of the biosamples. The separation of perindoprilat was achieved in-dependently on a phenomenex PFP column (4.6 mm × 150 mm, 5 μm). All the analytes were quantitated with positive electrospray ionization and multiple reactions monitoring mode. The assay exhibited a linear range of 1–250 ng/mL for indapamide, 0.4–100 ng/mL for perindopril and 0.2–20 ng/mL for peri-ndoprilat. The methods were fully validated to meet the requirements for bioassay in accuracy, precision, recovery, reproducibility, stabilities and matrix effects, and successfully applied to the pharmacokinetic study of perindopril tert-butylamine/indapamide compound tablets in Chinese healthy volunteers and the comparative pharmacokinetic study between plasma and whole blood.
ABSTRACT
Perindopril erbumine is a tert-butylamine salt of perindopril used in the treatment of stable coronary artery disease and hyperten-sion. The present study was aimed to evaluate the anaphylactic reaction as an adverse event for perindopril erbumine tablets. Electronic extraction of data from the safety database for this report includes all cases of anaphylactic reaction where perindopril was a primary or co-suspect drug. The study result have shown that there were overall 205 case reports for perindopril in the database, of which 200 cases were assessed as (potentially) perindopril and 05 were assessed as non-perindopril product. From the 200 case reports, 141 were serious and 59 were non-serious. Out of the 141 serious cases, 137 cases were medically confirmed while remaining 04 cases were consumer reports. Of the total 205 case reports there were five cases wherein the patient experienced anaphylactic reaction. The study concludes that three out of five cases entered in the drug safety database suggestive of a possible association between perindopril and anaphylactic reaction.
ABSTRACT
Perindopril erbumine is a tert-butylamine salt of perindopril used in the treatment of stable coronary artery disease and hyperten-sion. The present study was aimed to evaluate the anaphylactic reaction as an adverse event for perindopril erbumine tablets. Electronic extraction of data from the safety database for this report includes all cases of anaphylactic reaction where perindopril was a primary or co-suspect drug. The study result have shown that there were overall 205 case reports for perindopril in the database, of which 200 cases were assessed as (potentially) perindopril and 05 were assessed as non-perindopril product. From the 200 case reports, 141 were serious and 59 were non-serious. Out of the 141 serious cases, 137 cases were medically confirmed while remaining 04 cases were consumer reports. Of the total 205 case reports there were five cases wherein the patient experienced anaphylactic reaction. The study concludes that three out of five cases entered in the drug safety database suggestive of a possible association between perindopril and anaphylactic reaction.