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OBJECTIVE:To establish a method for the dissolution determination of Pentoxyverine citrate and guaifenesin tab-lets,and to compare the difference of preparations from different manufactures. METHODS:The paddle method was used to deter-mine the dissolution,using water as medium with medium volume of 1000 mL and rotation speed of 75 r/min,sampling at 45 min. HPLC method was used to determine the accumulative dissolution of pentoxyverine citrate and guaifenesin:CAPCELL PAK C18 MGⅡ S-5 column;mobile phase of acetonitrile-triethylamine phosphoric buffer solution(pH 2.6±0.05)(33:67,V/V),flow rate of 1.0 mL/min,detection wavelength of 215 nm(pentoxyverine citrate)and 275 nm(guaifenesin),column temperature of 35 ℃,sample size of 20 μL. RESULTS:The linear range of pentoxyverine citrate and guaifenesin were 5.0916-50.9155 μg/mL(r=0.9999)and 29.9995-299.9952 μg/mL(r=0.9999),respectively. RSDs of precision,stability and reproducibility tests were all lower than 2.0%. Average recoveries were 97.90%-100.68%(RSD=0.95%,n=9)and 97.09%-101.85%(RSD=1.32%,n=9). Average accu-mulative dissolution of pentoxyverine citrate in 6 manufactures of samples were 12%,98%,66%,97%,91%,32%(n=3);those of guaifenesin were 8%,95%,68%,90%,93%,18%(n=3),respectively. CONCLUSIONS:The method is simple,ac-curate,sensitive,specific and suitable for the dissolution determination of Pentoxyverine citrate and guaifenesin tablets. The dissolu-tion of samples between different manufactures and the same manufactures different batches are quite different.
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OBJECTIVE:To establish a method for determination of the dissolution of cibenzoline succinate tablets. METHODS: The content of cibenzoline succinate was determined by HPLC and computed based on the peak area in the external reference method. The chromatographic column was Diamonsil C18. The mobile phase consisted of acetonitrile-phosphoric acid(40∶60). The detective wavelength was set at 230 nm. The dissolution was determined by paddle method. RESULTS: The linear range of cibenzoline succinate was 1～40 ?g?mL-1(r=0.999 9) and the average recovery rate was 97.70%(RSD=0.14%).The dissolution rates of 3 batches of samples at 15 min were all above 80%.CONCLUSION: The established method is simple,rapid and accurate,and it is applicable for the determination of the dissolution of cibenzoline succinate tablets.
RESUMO
OBJECTIVE:To compare the dissolubilities of Tamoxifen citrate tablets from four domestic pharmaceutical factories METHODS:Rotating basket method and paddle method were used,and Td were calculated by Weibull distribution RESULTS:Statistical analysis showed that there were significant differences in Td among the products from different factories,and the dissolubility of the same product detected by rotating basket was slower than that by paddle method CONCLUSION:The dissolubilities of Tamoxifen citrate tablets have significant differences among four different domestic products