ABSTRACT
OBJECTIVE: To compare the similarity of the dissolution curves of cloperastine hydrochloride tablets in four kinds of dissolution media to provide reference for evaluating the consistency of the quality of domestic generics and revising the drug standards. METHODS: The dissolution curves of home-made and original patented cloperastine hydrochloride tablets in hydrochloric acid solution (pH 1.2), disodium hydrogen phosphate and citric acid buffer solution (pH 4.0), phosphate buffer solution (pH 6.8) and water were determined and the similarity was evaluated according to the AV values. RESULTS: In the four kinds of media, the AV values were more than 15.0. CONCLUSION: The dissolution behaviors of home-made and original patented cloperastine hydrochloride tablets in the four kinds of media are dissimilar, which indicates that the domestic generics urgently need to be improved in the prescription or the manufacturing process.
ABSTRACT
Objective: To investigate the electrochemiluminescence (ECL) behavior of cloperastine hydrochloride. Methods: ECL intensity of tris (2,2′-bipyridyl) rutheniumo(II) was enhanced, the method for the determination of cloperastine hydrochloride was established using capillary electrophoresis (CE) coupled with electrochemilumolinescence (ECL) detection. Results: Under the optimum conditions, ECL intensity varied linearly with cloperastine hydrochloride concentration from 7.0 × 10-6g/mL to 1.0 × 10-4g/mL. The detection limit (S/N=3) was 8.05 × 10-7 g/mL. The relative standard deviation of the ECL intensity and the migration time for 11 consecutive iajections of 1.0 × 10-5 g/mL cloperastine hydrochloride was 2.9% and 1.5%, respectively. This method was successfully applied to cloperastine hydrochloride tablet determination. Conclusion: The method has been established, validated and applied for determination of cloperastine hydrochloride.
ABSTRACT
OBJECTIVE:To determine the related substance in cloperastine hydrochloride by HPLC.METHODS:The analysis was conducted on Agilent C18 column with the mobile phase consisted of 0.02 mol?L-1 KH2PO4-methanol(30∶70,triethlaminel 1.0 mL,adjusted to pH=3.5 with phosphoric acid) at a flow rate of 1.0 mL?min-1.The detection wavelength was 225 nm;the column temperature was set at room temperature,and the injection volume was 20 ?L.RESULTS:Effective segregation was achieved for the related substance from the chief chromatographic peak.The total peak area of the related substance in the sample was 0.13%～0.26% that of the main constituent of its reference substance(own control solution).CONCLUSION:The method is simple,accurate and specific,and applicable for the quality control of the related substance in cloperastine hydrochloride.