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HPLC method for determination of clindamycin hydrochloride phosphate and its related substances of methodological research

Number of visits:1229 Date:2016/2/23 5:58:10
HPLC method for determination of clindamycin hydrochloride phosphate and its related substances of methodological research
Establish clindamycin hydrochloride method for determination of the content of phosphate and its related substances and methodology. Methods: using HPLC method, chromatography column for Li - chrospher C_ (18) column (46 mm, 250 mm x 5 microns); Column temperature 25 ℃; Mobile phase 0.1 mol · L ~ (1) of potassium dihydrogen phosphate buffer (adjust pH = 5.6) with 40% potassium hydroxide solution - acetonitrile (24) : 76; Flow rate: 1.2 mL · min ~ (1); : detection wavelength 210 nm. Results: compared with BP1998 and EP1997, table clindamycin hydrochloride - 2 - phosphate and another unknown impurities and clindamycin hydrochloride phosphate ester to obtain the very good separation; Linear range; Clindamycin hydrochloride - 2 - phosphate in 0.1 ~ 5.0 mg · mL ~ (1) a good line, r = 0.9996; Clindamycin phosphate hydrochlorideB - 2-0.0013 ~ 0.13 mg · mL ~ (1) had good linear, r = 0.9981; Table of clindamycin hydrochloride - 2 - phosphate in 0.0014 ~ 0.14 mg · mL ~ (1) had good linear, r = 0.9972; Clindamycin hydrochloride in 0.0011 ~ 0.11 mg · mL ~ (1) a good line, r = 0.9983; The minimum detection limit of 0.1 mu g; The minimum quantitative limit of 0.33 mu g. Conclusion: this law is better than the British pharmacopoeia and European pharmacopoeia can accurately determination of clindamycin hydrochloride content of phosphate and its related substances.

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