Analysis of Related Substances in Cetirizine Hydrochloride Oral Solution
OBJECTIVE To analyze the impurities in cetirizine hydrochloride oral solution,and explore the existing problems of the production process,and provide a reference for improvement of the product quality.METHODS The related substances of 3 manufactures'cetirizine hydrochloride oral solution were determined by HPLC.The main impurities were studied qualitively and quantitatively.The chromatographic separation was performed on a CAPCELL PAK C18(4.6 mm×250 mm,5 μm)column with a mixture of acetonitrile-water(17∶83)(phosphoric acid adjusted to pH 1.5)and acetonitrile-water(35∶65)(phosphoric acid adjusted to pH 1.5)as mobile phase by gradient elution.Detection wavelength was set at 230 nm.The confirmatory structure of the main impurities was determined by chromatography-mass spectrometry,the compatibility test between raw materials and pharmaceutical excipients was established to determine the pathway of impurities.The chromatographic separation was performed on an ACQUITY UPLC HSS-C18(150 mm×2.1 mm,1.7 μm)column with 20 mmol·L-1 ammonium acetate(with 0.1％acetic acid)-methanol as mobile phase by gradient elution.RESULTS There might be 5 impurities in cetirizine hydrochloride oral solution.The two main related substances detected in cetirizine hydrochloride oral solution from 3 enterprises were cetirizine propylene glycol esters(a pair of diastereomers)and cetirizine glycerides(a pair of diastereomers).The emergence of impurities was highly relater to the formulation process.CONCLUSION The formulation technology of cetirizine hydrochloride oral solution need to be improved,and the active ingredients are incompatible with excipients.The related substances of cetirizine hydrochloride oral solution should be controlled from formulation design to improve the quality.
cetirizine hydrochloride oral solutionrelated substancescetirizine propylene glycol esterscetirizine glyceridesquality control
万方数据
维普
