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Analysis of Related Substances in Josamycin and Josamycin Tablets by HPLC / 中国药师
China Pharmacist ; (12): 1980-1983, 2014.
Article in Chinese | WPRIM | ID: wpr-460071
ABSTRACT

Objective:

To establish a determination method for the related substances in josamycin and josamycin tablets by HPLC.

Methods:

High performance liquid chromatography was used. The column was Ultimate-AQ-C18(250 mm ×4.6 mm,5 μm), the mobile phase respectively was mobile phase A of 0. 2 mol·L-1 tetrabutylammonium hydrogen sulphate R-0. 2 mol·L-1 disodium hydrogen phosphate(pH 3. 0)-acetonitrile R-water(3∶5∶24∶68) and mobile phase B of 0. 2 mol·L-1 disodium hydrogen phosphate (pH 3. 0)-acetonitrile R-water(5∶50∶45). The flow rate was 1. 5 ml·min-1 with the detection wavelength of 232nm. The column temperature was 50℃.

Results:

The main component josamycin had a good separation with the other related substances. The resolution between josamycin and the related substances with the relative retention time of 1. 1-fold of josamycin was above 1. 7. The detection limit of josamycin was 1. 43ng. In josamycin raw materiel and josamycin tablets, the percentage of related substance A and B was less than 1. 5%. The percentage of related substance D was below 2. 0%. The percentage of related substance E was less than 3. 0%. The percentage of the other maximum related substances was less than 1. 0%. The percentage of all related substances was less than 12%. The percentage of related substance C was less than 1. 0% in josamycin raw materiel while 3. 0% in josamycin tablets.

Conclusion:

The method is accurate, sensitive and reliable in the determination of related substances in josamycin and josamycin tablets.

Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacist Year: 2014 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacist Year: 2014 Type: Article