The Methodological Research Of Quality Control For Compound Reserpine Tablets

Objective:1. To establish the determination content of three magnesium silicate, potassium chloride method in the compound reserpine tablets.2. To establish the determination content of calcium pantothenate, hydrochlorothiazide, vitamin B6, double hydrazine sulfate flexor lamictal and vitamin B1method in the compound reserpine tablets at the same time.3. To research the dissolution curve of compound reserpine tablets.4. To research the related substance of compound reserpine tablets. Method:1. Used FAAS to measure the content of three magnesium silicate, potassium chloride in the compound reserpine tablets.2. Used HPLC to measure the content of calcium pantohenate, hydrochlorothiazide, vitamin B6, double hydrazine sulfate flexor lamictal and vitamin B1in the compound reserpine tablets at the same time.3. Used a variety of dissolution medium, HPLC determination to inspect the dissolution curve of the sample.4. Used the destructive test to measure the content changes of calcium pantothenate, hydrochlorothiaz-ide, vitamin B6, double hydrazine sulfate flexor lamictal and vitamin B1in the compound reserpine tablets. Result:The linear range of three magnesium silicate was0.19-14.98mg/L, r=0.9965, the precision was0.6%RSD (n=9), the repeatability was0.8%RSD(n=9), the average recovery was90.6%,1.6%RSD(n=9);The linear range of three magnesium silicate, potassium chloride was0.67～13.46mg/L, r=0.9990, the precision was0.5%RSD (n=9), the repeatability was0.8%RSD(n=9), the average recovery was101.1%,1.7%RSD (n=9).2. The linear range of calcium pantothenate was2.16-29.76mg/L, r=0.9996, the precision was1.4%RSD (n=9), the repeatability was1.3%RSD(n=9), the average recove-ry was97.0%,1.1%RSD(n=9); The linear range of hydrochlorothiazide was6.29～94.30mg/L, r=0.9997, the precision was0.6%RSD (n=9), the repeatability was1.5%RSD(n=9), the average recovery was99.1%,0.6%RSD(n=9); The linear range of vitamin B6was1.97～29.54mg/L, r=0.9996, the precision was1.1%RSD (n=9), the repeatability was1.5%RSD (n=9), the average recovery was96.7%,1.0%RSD(n=9);The linear range of double hydrazine sulfate flexor oxazine was8.45～126.8mg/L, r=0.9997, the precision was1.1%RSD (n=9), the repeatability was1.7%RSD (n=9), the average recovery was96.7%,1.3%RSD(n=9);The linear range of vitamin B1was1.97～29.54mg/L, r=0.9997, the prec-ision was1.1%RSD (n=9), the repeatability was1.4%RSD (n=9), the average recovery was98.1%,1.2%RSD(n=9);3. Different enterprise production of compound reserpine tablets and reference enterprise production of compound reserpine tablets compared to still has certain gap.4.The destructive test of compound reserpine tablets in calcium pantothen-ate, hydrochlorothiazide, vitamin B6, double hydrazine sulfate flexor lamictal and vitamin B1had different degrees of influence.Conclusion:1.FAAS determination of compound reserpine tablets in the content of three magnesium silicate, potassium chloride to revise the quality standards of compound reserpine tablets laid a foundation.2. HPLC determina-tion content of compound reserpine in calcium pantothenate, hydrochlorothiazide, vitamin B6, double hydrazine sulfate flexor lamictal and vitamin B1, to the quality control of compound reserpine tablets provides the reference.3. This experiment chooses conditions of4kinds of stripping effect is good, can be used to compound reserpine tablets of bioe-quivalence study.4. The destructive test provided a possible degradation pathway and degradation products of relevant information of compound reserpine tablets...