Fast performance liquid chromatography with conventional high-performance liquid chromatography determination of clindamycin phosphate and its related substances in comparison.docVIP

 PAGE \* MERGEFORMAT 9 Fast performance liquid chromatography with conventional high-performance liquid chromatography determination of clindamycin phosphate and its related substances in comparison Author: Zhang Jin-Ming-Je Shiu Dou Sheng Li XIANG Bing-Ren HU Chang-Qin Wang Chen Lei Yao [Abstract] Objective To compare the analysis of fast-performance liquid chromatography (UFLC) with conventional liquid chromatography (HPLC) determination of clindamycin phosphate content and related substances. Methods UFLC France Waters C18 column using hybrid column (50mm * 4.6mm, 2.5μ m), flow rate 1.5ml/min; HPLC method using column Apollo C18 (250mm * 4.6mm, 5μ m), flow rate 1.0ml/min. Two methods are 0.1mol / L potassium dihydrogen phosphate (85% of the phosphoric acid adjusted pH3.5): acetonitrile: methanol (700:150:150) as mobile phase, detection wavelength 210nm. Results UFLC law, clindamycin phosphate in 0.01 ~ 1.5mg/ml showed good linearity, r = 0.9999; the minimum detection limit of 20ng; the lowest limit of quantification of 60ng; precision RSD of 0.41%. Compared with HPLC, the determination of clindamycin phosphate content of fast, accurate and sensitive; but the determination of related substances, their specificity and accuracy than HPLC, the number of impurities detected in small and incomplete separation of some impurities. Conclusion UFLC method can be accurate, rapid and efficient determination of clindamycin phosphate content, suitable for a large workload test items, such as content preparation, content uniformity and dissolution of the application; but by the simple way to convert established UFLC method usually could not do the right drug complex systems, such as the analysis of related substances. [Keywords:] Fast liquid chromatography; high-performance liquid chromatography; clindamycin phosphate; related substances ABSTRACT Objective To compare and analyze the UFLC and HPLC method for determination of the content of clindamycin phosphate and its