ABSTRACT
New Dihydroartemisinin Tablets were prepared,and a new dissolution determination method for the tablets was established,which provides reference for revising the quality standard.The dissolution experiment adopted the paddle method with 0.1 mol·L~(-1)hydrochloric acid solution 250 m L as the solvent,the rotating speed of 100 r·min~(-1)and the sampling time of 30 min.HPLC was adopted to determine the dissolution of dihydroartemisinin.The determination was performed on Agilent Eclipse XDB-C_(18)column with the mobile phase of acetonitrile-water(40∶60)at the flow rate of 1.0 m L·min~(-1).The detection wavelength was set at 216 nm,and the column temperature was 30℃.The sample size was 100μL.The linear range of dihydroartemisinin were 1.234 5-79.003 ng(r=1.000 0).The limit of quantitation was 0.308 6 ng,and the limit of detection was 0.154 3 ng.RSDs of precision tests were all lower than 1.0%.The recoveries were 98.09%-102.6%(RSD 1.8%,n=9).The average dissolutions of dihydroartemisinin in 3 batches of samples were 93.81%,92.61%,92.37%,respectively.The determination method is highly reproducible,accurate and reliable,and can objectively reflect the dissolution of Dihydroartemisinin Tablets,and provide a basis for revising the dissolution test of the current quality standard.Based on the dissolution rate,new tablets are superior to original tablets.
Subject(s)
Artemisinins , Chemistry , Chromatography, High Pressure Liquid , Solubility , TabletsABSTRACT
OBJECTIVE:To improve the detection method for the dissolution of dihydroartemisinin in Dihydroartemisinin and piperaquine phosphate tablets. METHODS:The dissolution experiment adopted paddle method using 0.1 mol/L hydrochloric acid so-lution 500 mL as solvent with rotating speed of 75 r/min and sampling time of 45 min. In sample pre-treatment,the volume of 3.6% sodium hydroxide solution was increased from 5 mL to 20 mL,and that of phosphoric acid was increased from 0.2 mL to 0.7 mL. HPLC was adopted to determine the dissolution of dihydroartemisinin. The determination was performed on YMC-Pack ODS-A column with mobile phase consisted of 0.02 mol/L disodium hydrogen phosphate solution(pH adjusted to 2.4 using phosphoric ac-id)-acetonitrile(65 : 35,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 237 nm,and column temperature was 30 ℃. The sample size was 20 μL. RESULTS:The linear range of dihydroartemisinin were 7.802-117.03 μg/mL(r=0.9999). The limit of quantitation was 2.0 ng,and the limit of detection was 0.6 ng. RSDs of precision and reproducibility tests were all low-er than 1.0%. The recoveries were 99.18%-100.46%(RSD=0.45%,n=9). Average dissolutions of dihydroartemisinin in 3 batch-es of samples were 94.9%,77.9%,89.6%,respectively. CONCLUSIONS:Improved method enhance the accuracy for the limit of sensitivity,dissolution and detection results.
ABSTRACT
Gypsum as a common mineral medicine is widely used in clinics, which is mainly used for the treatment of all kinds of fever. Through reviewing the historical document records of gypsum, the effects of the mineral resources and production process on the quality, and the quality studies were investigated in order to guide the production process,the preparation process and decoction pieces classification of gypsum, and further expand the effective application of gypsum in clinics.
ABSTRACT
OBJECTIVE: To discuss the role of proficiency testing program for pharmaceutical dissolution determination in the capacity building of relevant laboratories. METHODS Based on the results of the two proficiency testing programs carried out in recent years, analyze the difference of the quality management and the level of dissolution determination among the participating laboratories and discuss on the way that the proficiency testing programs carried out in future. RESULT: There is difference among the laboratories in both the quality management and the level of dissolution determination, the "unsatisfactory" laboratories mainly concentrated in local drug control institutes and pharmaceutical manufacturers. The three "unsatisfactory" laboratories in the first program, took corrective and preventive measures, participated in the later program, and achieved "satisfactory" results. CONCLUSION: The proficiency testing program is effective in improving the dissolution determination capacity of the participating laboratories and is recommended to be conducted continually in the pharmaceutical industry.