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Analytical method of tedizolid phosphate and related substances thereof

A technology of tedizolid phosphate and analysis method, which is applied in the directions of analysis materials, material separation, measuring devices, etc., can solve the problems such as no loading of tedizolid phosphate, and achieve the effects of good specificity, improved work efficiency and low cost

Active Publication Date: 2017-09-01
NANJING YOKO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the quality standard of tedizolid phosphate is not included in the current version of "European Pharmacopoeia" and its pharmacopoeia forum, "US Pharmacopoeia" and its pharmacopoeia forum, and Chinese Pharmacopoeia 2015 edition

Method used

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  • Analytical method of tedizolid phosphate and related substances thereof
  • Analytical method of tedizolid phosphate and related substances thereof
  • Analytical method of tedizolid phosphate and related substances thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] High performance liquid chromatography analysis of embodiment one tedizolid phosphate and several related substances

[0040] Several related substances are: BP13, BP20, BP22, BP23, BP25, BP26, BP42, DDG02, DDG14, INA, INA08, SMA, TDPEN

[0041] Instruments and analysis conditions——Shimadzu 2010 or Agilent1100 for high-performance liquid chromatography; Waters Xterra C18 (150*4.6mm, 3.5μm) for chromatographic column; octadecylsilane bonded silica gel as filler; detection wavelength is 300nm; with 25mmol / L ammonium acetate (adjust pH to 8.5 with ammonia water) as mobile phase A, with acetonitrile:tetrahydrofuran (90:10) as mobile phase B, flow rate is 1.0ml / min; column temperature is 40°C; theoretical plate The number is not less than 3000 based on the peak of tedizolid phosphate; carry out gradient elution according to the following table:

[0042] time (min) Mobile phase A(%) Mobile phase B(%) 0 99 1 30 53 47 40 53 47 42 99 1 5...

Embodiment 2

[0054] The methodological investigation of the analytical method of the present invention of embodiment two

[0055] 1. System applicability inspection

[0056] Solution preparation:

[0057] Resolution test solution: Take an appropriate amount of BP13, BP20, BP22, BP23, BP25, BP26, BP42, DDG02, DDG14, INA, INA08, SMA and tedizolid phosphate reference substance respectively, add mobile phase A to make quantitative dilution into each 1ml A mixed solution containing 1.25 μg of other impurities and 250 μg of tedizolid phosphate was used as the resolution solution.

[0058] Need testing solution: Take about 25 mg of tedizolid hydrochloride phosphate reference substance, accurately weigh it, put it in a 100ml measuring bottle, add mobile phase A to dissolve and dilute to the scale, shake well, and use it as the testing solution;

[0059] Control solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase A to dilute to the mark, sha...

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Abstract

The invention provides an analysis and detection method capable of simultaneously determining tedizolid phosphate and related substances thereof. Through a high performance liquid chromatograph, a sample is dissolved by using an ammonium bicarbonate water solution, an acetonitrile-tetrahydrofuran mixed solvent is taken as an organic phase, an ammonium salt water solution or a mixed liquor of an ammonium salt water solution and alkali selected from liquid ammonia, ammonium hydroxide or triethylamine is taken as a buffer solution, and gradient elution is carried out on an octadecyl silane bonded silica gel chromatographic column. The method provided by the invention is good in specificity, high in sensitivity and good in degree of separation, repeatability, degree of precision and linear relation respectively, the substances can be effectively detected when being equivalent to more than 0.03% of main ingredients, the substances can be accurately quantified when being equivalent to less than 0.05% of the main ingredients, the method is applicable to impurity control, and the requirement of related substance checking can be met.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for separating and measuring tedizolid phosphate and its related substances by high performance liquid chromatography. Background technique [0002] Tedizolid phosphate (Tedizolid phosphate, formula (I)) is an oxazolidinone antibiotic developed by Cubist Pharmaceuticals, which was approved by the FDA on June 10, 2014. The trade name is Sivextro, for the treatment of acute bacterial skin and skin structure infections caused by Staphylococcus aureus and Gram-positive bacteria such as various Streptococcus species and Enterococcus faecalis. Tedizolid phosphate belongs to the oxazolidinone antibiotics, and it is not easy to produce cross-resistance with other antibiotics. Compared with the first oxazolidinone antibiotic, Linezolid, it has better efficacy and higher safety. [0003] [0004] The related substances are mainly the starting materials, intermediates, polymers, si...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张峰骆杨丽姚洛芫朱素华薛峪泉
Owner NANJING YOKO PHARMA
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