A. Saad, M. Draz, Ibrahim A. Naguib
Feb 6, 2022
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Journal
Biomedical chromatography : BMC
Abstract
Cyclizine hydrochloride (CYC) and Meclozine hydrochloride (MEC) are antihistaminic drugs generally co-formulated with Pyridoxine hydrochloride (PYR) to treat nausea and vomiting in pregnancy. Several analytical techniques were applied for determination of CYC or MEC with PYR but no one paid attention to determination of CYC impurity; Benzhydrol (BEH) or MEC impurity; 4-Chlorobenzophenone (BEP). Therefore, micellar Ultra performance liquid chromatographic (UPLC) method is introduced for analysis of ternary mixtures containing PYR together with both CYC and BEH (mixture I) or MEC and BEP (mixture II). Chromatographic separation was achieved using Hypersil gold C8 column (50 mm x 2.1 mm, 1.9 μm) using 0.01M sodium dodecyl sulphate modified to pH 3.5 using phosphoric acid: acetonitrile (45:55 by volume) for mixture I and (0.1 % sodium dodecyl sulphate, 0.1% sodium bicarbonate adjusted to pH 2.6 by phosphoric acid): acetonitrile (47: 53 by volume) for mixture II as mobile phases. The separated peaks were detected at 230 nm and 245 nm for mixture I and II, respectively. The adopted methods were validated in consent to the International conference on harmonization (ICH) recommendations and were properly applied in commercial pharmaceutical formulations analysis. Comprehensive ecological comparison was achieved confirming higher ecological value of the presented methods compared to the reported methods.