Valganciclovir hydrochloride impurity analytical detecting method

A valganciclovir hydrochloride and detection method technology, which is applied in the field of analysis and detection of valganciclovir hydrochloride impurities, can solve problems such as separation difficulties, and achieve the effects of high sensitivity, good linear relationship, and easy operation
CN104749286AActive Publication Date: 2015-07-01HUBEI LIYI PHARM TECH CO LTD +1
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
HUBEI LIYI PHARM TECH CO LTD
Publication Date
2015-07-01

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Abstract

The invention belongs to the technical field of the analytical chemistry and in particular discloses a valganciclovir hydrochloride impurity HPLC (High Performance Liquid Chromatography) analytical detecting method, and more specifically, the invention relates to a method for analytically detecting guanine, ganciclovir, methoxymethylguanine, ganciclovir 1-N-methyl-valine, mono acetoxyl ganciclovir, mono chloro ganciclovir or a medicine or a preparation containing the above six impurities. A solution to be detected is filled in a high performance liquid chromatographic column taking phenylsilane bonded silica gel as a filling agent, a moving phase prepared by an amine-containing aqueous inorganic salt solution and a chromatographically pure organic solvent is adopted to wash and separate, and then ultraviolet analysis and detection is carried out. According to the method, ammonium acetate or ammonium formate with certain concentration is firstly added in the moving phase creatively, and difficult problems that the main peak and the impurity peak and the adjacent impurity peaks are separated difficultly are thoroughly solved, the operation is simple, the separation degree is high, the sensitivity is high, the accuracy is good, and no similar literature is reported through literature retrieval.
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Description

technical field

[0001] The invention relates to the technical field of analytical chemistry, in particular to a method for analyzing and detecting valganciclovir hydrochloride impurities by HPLC, more specifically, to a method for analyzing and detecting guanine, ganciclovir, and methoxymethylguanine , ganciclovir 1-N-methyl valine ester, monoacetoxy ganciclovir, monochloroganciclovir or a drug or preparation thereof containing the impurities in the above 6. Background technique

[0002] Valganciclovir hydrochloride raw materials may produce six main impurities during the synthesis process and during the placement of valganciclovir hydrochloride solid preparations, namely guanine, ganciclovir, and methoxymethylguanine , Ganciclovir 1-N-methyl valine ester, monoacetoxy ganciclovir, monochloroganciclovir.

[0003] Above-mentioned 6 kinds of impurity, how much its content directly affects the quality of valganciclovir hydrochloride or its preparation, easily causes human body ...

Claims

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