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Application of supercritical fluid chromatography for separation and quantitation of 15 co‐formulated binary anti‐hypertensive medications using a single elution protocol
Author(s) -
Pandya Pranav A.,
Shah Priyanka A.,
Shrivastav Pranav S.
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.5035
Subject(s) - chemistry , chromatography , hydrochlorothiazide , elution , analyte , supercritical fluid chromatography , resolution (logic) , detection limit , olmesartan , atenolol , analytical chemistry (journal) , column chromatography , medicine , artificial intelligence , computer science , blood pressure , radiology
A facile supercritical fluid chromatography method is proposed to analyse 15 co‐formulated binary anti‐hypertensive drug combinations using a customized elution procedure. The effect of mobile phase composition, column back pressure and temperature was suitably optimized for adequate retention, analyte response and resolution. The chromatographic separation of the different drug combinations was performed on a DCPak poly(4‐vinylpyridine) column (250 × 4.6 mm, 5 μm) at 125‐bar pressure and 40°C using a photodiode array detector. A linear gradient of CO 2 and 0.1% formic acid in methanol provided the best elution conditions for all drug combinations. Baseline separation of the drugs was possible with resolution factor R s ranging from 1.42 to 12.58. The method was validated for specificity, sensitivity, accuracy and precision, recovery and robustness. The limit of detection and limit of quantitation for aliskiren, amlodipine, atenolol, candesartan, hydrochlorothiazide, lisinopril, losartan, metoprolol, olmesartan, telmisartan and valsartan were in the range of 0.26–2.56 and 0.77–7.75 μg/mL, respectively. The thermodynamic study revealed that interactions of the drugs with the stationary phase were spontaneous as evident from the negative free energy values, and the separation process was enthalpy driven. The developed method was successfully employed to analyse these drugs in their co‐formulated tablet formulations.