RP-HPLC determination of azithromycin soft capsules.docVIP

 PAGE \* MERGEFORMAT 21 RP-HPLC determination of azithromycin soft capsules [Abstract] Objective RP-HPLC method for determination of azithromycin azithromycin soft capsule content. Methods alkali resistance of the 18 alkyl silane bonded silica gel column as the stationary phase, water: 0.01mol / L disodium hydrogen phosphate solution (pH value is adjusted with sodium hydroxide test solution to 10.3): acetonitrile (16.7:23.3 : 60) as mobile phase, flow rate 1.5ml/min, column temperature 40 ℃ , detection wavelength 210nm. The results of principal component Azithromycin impurity peak separation of adjacent peaks and good; blank vegetable oil excipients do not interfere with the main components of azithromycin separation and detection. Azithromycin in the concentration range of 0.2052 ~ 1.9207μ g/ml within the quality and peak area showed good linear relationship; in to add a blank oil excipient system in terms of the concentration range of 0.1995 ~ 2.0147μ g/ml within the quality and peak area showed good linear relationship. With the addition of a blank oil excipient system azithromycin lowest detectable concentration was 1.0483 ~ 2.0966μ g/ml, the minimum detectable concentration in plasma of 4.1932 ~ 10.483μ g/ml. The average recovery accuracy of the test 101.4%, RSD of 0.2% (n = 9); repetitive tests, the average content of 98.0%, RSD of 1.0% (n = 9). Conclusions The method is specific, precise, accurate, durable, alternative to microbiological assays of antibiotics azithromycin soft gelatin capsules as a method for the determination. [Keywords:] high-performance liquid chromatography; azithromycin; soft capsule; determination ABSTRACT Objective To established a high performance liquid chromatography method for determination of azithromycin soft capsules. Methods A high pH stability column (Agilent Zorbax Extend-C18, 4.6mm * 150mm, 5μ m) was used; the mobile phase consisted of water: 0.01mol / L dibasic sodium phosphate buffer solution (the pH value was adju