ABSTRACT
Objective:To compare the dissolution of domestic terazosin hydrochloride tablets and capsules to provide reference for clinical use. Methods:The dissolution of the products from different manufacturers was investigated respectively in 4 kinds of media:pH 1. 0 hydrochloric acid solution,pH 4. 5 phosphate buffer solution,pH 6. 8 phosphate buffer solution and water. The dissolution tests were carried out by a paddle method at the stirring speed of 50 r·min-1 and an HPLC method was used to determine the dissolution rate. The dissolution behavior of the samples from different manufacturers was compared by a similar factor method. Results:The do-mestic tablets showed higher similarity with the reference formula, and the dissolution behavior of the capsules had significant differ-ence. Conclusion:The calculation method for the specification in some manufacturers is different from that of the reference prepara-tion, which leads to the difference between the testing preparation and the reference preparation, and should be paid attention in clini-cal use.
ABSTRACT
Objective:To establish an HPLC method for the determination of compound proglumide tablets. Methods:A Diamon-sil C18(250 mm ×4.6 mm,5 μm)column was used. The mobile phase was 2% ammonium acetate-methanol (40∶60), the detection wavelength was 225nm, and an external standard method was employed. Results:The linear range of proglumide was 2. 60-208. 10 μg (r=0. 999 9), and the average recovery was 99. 8%(n=6,RSD=0. 6%). Conclusion: The HPLC determination method for com-pound proglumide tablets is accurate, simple and reproducible.
ABSTRACT
Determined the easily oxidized substance of the injector based on GB15810-2001, and analyzed the source of uncertainty of the process of titration symmetrically, and valued the uncertainty of the result of data analysis.
