Method for determining content of effective components of pirfenidone tablets

A technology for pirfenidone tablets and active ingredients, applied in the field of medicine, can solve the problems of rarely reported content determination methods of pirfenidone tablets and the like, and achieve the effects of effective quality control and convenient determination methods

Pending Publication Date: 2022-03-01
JIANGSU SEMPOLL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the prior art, there are few reports on the content determination method of pirfenidone tablets, and as a medicine, it is very necessary to strictly control its content when it leaves the factory

Method used

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  • Method for determining content of effective components of pirfenidone tablets
  • Method for determining content of effective components of pirfenidone tablets
  • Method for determining content of effective components of pirfenidone tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0029] (1) Inspection of linear relationship:

[0030] Accurately weigh an appropriate amount of pirfenidone reference substance, add mobile phase to dissolve and dilute to make a stock solution of 0.2 mg / ml, and use mobile phase to gradually dilute to concentrations of 0.05 mg / ml, 0.08 mg / ml, and 0.10 mg / ml , 0.12mg / ml, and 0.15mg / ml solutions, respectively accurately measure 10 μ L of each solution and inject it into a liquid chromatograph, and record the chromatogram; take the pirfenidone peak area (A) as the ordinate, and the concentration of the pirfenidone solution (C) is the abscissa, and the regression equation y=34388x+5.0634 (R 2 =1.000), such as figure 1 , the results showed that pirfenidone had good linearity in the range of 0.051-0.154mg / mL.

[0031] (2), accuracy test:

[0032] Accurately weigh about 16mg, 20mg, and 24mg of pirfenidone samples in three parts, place them in 20ml volumetric flasks respectively, add mobile phase to dilute to the mark, shake well,...

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Abstract

The invention discloses a method for detecting the content of effective components in pirfenidone tablets, which comprises the following steps of: taking a proper amount of ground pirfenidone tablet sample, putting the ground pirfenidone tablet sample into a volumetric flask, adding a mobile phase, dissolving and diluting to obtain a test solution; taking a proper amount of a pirfenidone reference substance, placing the pirfenidone reference substance in a volumetric flask, and dissolving and diluting the pirfenidone reference substance with a mobile phase to obtain a reference substance solution; precisely measuring 10 microliters of the test solution and 10 microliters of the reference solution, respectively injecting the test solution and the reference solution into a high performance liquid chromatograph, and recording chromatograms, isocratic elution is carried out by using octadecylsilane chemically bonded silica as a filler and water-acetonitrile as a mobile phase, the determination method is convenient, accurate and reliable, and effective control on the quality of the pirfenidone tablet can be realized.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for determining the content of active ingredients in pirfenidone tablets. Background technique [0002] Pulmonary fibrosis (PF) is the end stage of many heterogeneous diseases, and to some extent is a hallmark of interstitial lung disease. It is characterized by excessive deposition of extracellular matrix proteins in the lung interstitium, leading to loss of functional alveolar units and, in most cases, death from respiratory failure. While a small number of interstitial lung diseases have known causes, most are idiopathic in nature, with idiopathic pulmonary fibrosis (IPF) being the most common form. IPF is a disease with poor prognosis, strong heterogeneity, and unpredictable. Its prevalence is currently estimated to be (14-43) / 100,000, and it increases with age. The median survival time after IPF diagnosis In about 3 to 4 years, based on the current serious situat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 刘永波徐瑞田陈玉兰蔡蓓蕾
Owner JIANGSU SEMPOLL PHARMA
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