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A sensitive and efficient LC–MS/MS method for the bioanalysis of fosinopril diacid from human plasma and its application for a bioequivalence study in humans
Author(s) -
Bhende Swati D.,
Varanasi Murali Balaram,
Abbulu Konde
Publication year - 2021
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.5047
Subject(s) - chemistry , fosinopril , chromatography , bioequivalence , benazepril , electrospray ionization , selected reaction monitoring , analyte , bioanalysis , solid phase extraction , ammonium acetate , mass spectrometry , tandem mass spectrometry , high performance liquid chromatography , bioavailability , angiotensin converting enzyme , pharmacology , radiology , medicine , blood pressure
Fosinopril diacid is an angiotensin converting enzyme inhibitor with efficient antihypertensive action. It is an active metabolic product formed in the body from hydrolysis of its prodrug Fosinopril. A sensitive, rapid method with high recovery for Fosinopril diacid from human plasma was developed. Solid‐phase extraction technique employing Waters Oasis SPE cartridges gave clean samples with very high recovery of 97%. The analyte along with its internal standard (Benazepril hydrochloride) were chromatographed on an XTerra RP 8 column (4.6 × 50 mm, 5 μm) using methanol–ammonium acetate buffer (10 m m; 90:10, v/v) as the mobile phase. A triple quadrupole mass spectrometer equipped with electrospray ionization source operated in the negative ion mode was used for detection. Multiple reaction monitoring scan mode was used for monitoring the transitions from m / z 434.00 → 237.15 for Fosinopril diacid and m / z 423.10 → 174.00 for Benazepril hydrochloride. Beer–Lambert’s law was obeyed in the range of 0.50–1,500.00 ng/ml ( r = 0.9993). The stability of the drugs in human plasma and in stock solution was proved by performing stability tests as per US Food and Drug Administration guidelines. The method was successfully applied for a bioequivalence study of Fosinopril diacid in 36 healthy, adult, male volunteers under fasting conditions.