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The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Patent No.:

US 11046723 B1

PDFFull Text
Date of Patent:
Jun. 29, 2021

Filed:

Dec. 14, 2018

Process of controlling the impurities of clindamycin hydrochloride

Applicant:

Zhaoke (Guangzhou) Ophthalmic Drug Company Limited, Guangzhou, CN;

Inventors:

Dongsheng Ni, Guangzhou, CN;

Jing Liu, Guangzhou, CN;

Gang Li, Guangzhou, CN;

Xiangrong Dai, Guangzhou, CN;

Xiaoyi Li, Guangzhou, CN;

Assignee:

ZHAOKE (GUANGZHOU) Ophthalmic Drug Company Limited, Guangzhou, CN;

Attorney:
Primary Examiner:

Jonathan S Lau

Int. Cl.
CPC ...
C07H 15/16 (2006.01); C07H 1/06 (2006.01); G01N 30/88 (2006.01); B01D 15/14 (2006.01); B01J 20/10 (2006.01); B01J 20/28 (2006.01); G01N 30/34 (2006.01); G01N 30/36 (2006.01); G01N 30/60 (2006.01);
U.S. Cl.
CPC ...
C07H 15/16 (2013.01); B01D 15/14 (2013.01); B01J 20/103 (2013.01); B01J 20/2803 (2013.01); C07H 1/06 (2013.01); G01N 30/88 (2013.01); B01J 2220/54 (2013.01); G01N 30/34 (2013.01); G01N 30/36 (2013.01); G01N 30/60 (2013.01); G01N 2030/6013 (2013.01); G01N 2030/8872 (2013.01);
Abstract

The invention provides a process of controlling the impurities of clindamycin hydrochloride, comprising a step of purifying said clindamycin hydrochloride by two-phase high performance liquid chromatography, wherein the chromatographic conditions are as follows: the detection wavelength is 200-220 nm; the column temperature is 20-40° C.; the flow rate is 0.8-1 ml/min; Mobile phase A: 0.025 mol/L potassium dihydrogen phosphate solution; Mobile phase B: Acetonitrile; and gradient elution is performed. The method of controlling impurities of the invention can solve the problem of the interference by excipients and the problem of the separation of many impurities at the same time. It also provides an effective method for setting quality standard of impurities in such a formulation.

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