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OBJECTIVE:To establishment the method for the determination of content of vitamin A palmitate(VAP) and its related substances by HPLC. METHODS:The HPLC conditions were consisted of Phenomenex Luna C18 column with a mobile phase of a mixture of acetonitrile-isopropanol (90∶10) ,the detection wavelength of 328 nm,the column temperature of 30 ℃ and the flow rate of 1.0 mL?min-1. RESULTS:VAP was completely separated from impurities,the linearity range was 90～400 mg?L-1(r=0.999 2). The average recovery rate was 99.60% (RSD=1.32%). The average content of the related substances were lower than 2.53% . CONCLUSION: This accurate and reliable HPLC method is applicable for the quality control of VAP.
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OBJECTIVE:To establish an RP-HPLC method for content determination of s-omeprazole sodium and its related substances.METHODS:The separation of s-omeprazole sodium and the related substances was carried out on a Phenomenex Luna C18 column,the mobile phase consisted of methanol-0.033 mol?L-1 ammonium dihydrogen phosphate-triethylamine (58∶41.8∶0.2,adjusted to pH 7.0 by phosphate acid).The detection wavelength was 302 nm,the flow rate was 1.0 mL?min-1,the column temperature was 25 ℃,and the sample size was 20 ?L.RESULTS:The linear range of omeprazole sodium was 10～500 mg?L-1 (r=0.999 7).The average recovery rate was 100.27% (RSD=0.74%).The average content of the related substances in samples was 0.42%.CONCLUSION:This method is simple,accurate,specific and applicable for content determination of s-omeprazole sodium and its related substances.
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OBJECTIVE: To establish a HPLC method for the determination of content of entecavir and its related substances. METHODS: The HPLC condition was consisted of a Luna C18 column with a column temperature at 25 ℃, using gradient eluate method, the mobile phase was acetonitrile,with a flow rate of 1.0 mL?min-1 and detection at 254 nm. RESULTS: The calibrated linear curve of entecavir was within 0.033 45～0.167 2 mg?mL-1(r=0.999 98). The average recovery was 100.09%,RSD=0.20%, The content of related substance was 0.54%～1.48%. CONCLUSION: This accurate and reliable HPLC method is applicable for the quality control of entecavir and its related substances.