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A High Performance Liquid Chromatography Method for Simultaneously Separating and Analyzing Paricalcitol and Isomer Impurities in Paricalcitol Injection

A high-performance liquid chromatography, paricalcitol technology, applied in the field of analytical chemistry, can solve the problems of no literature report, no proposed detection method for separation and analysis of isomer impurities, and achieves the effect of high accuracy and avoiding interference

Active Publication Date: 2020-11-06
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the fact that the existing quality standard JX20060114 of Paricalcitol Injection does not propose a separation and analysis method for the detection of isomer impurities, and there is no relevant literature report

Method used

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  • A High Performance Liquid Chromatography Method for Simultaneously Separating and Analyzing Paricalcitol and Isomer Impurities in Paricalcitol Injection
  • A High Performance Liquid Chromatography Method for Simultaneously Separating and Analyzing Paricalcitol and Isomer Impurities in Paricalcitol Injection
  • A High Performance Liquid Chromatography Method for Simultaneously Separating and Analyzing Paricalcitol and Isomer Impurities in Paricalcitol Injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Example 1 Simultaneous separation and analysis of Paricalcitol and isomer impurities in Paricalcitol Injection

[0067] 1. Reference substance solution: keep away from light. Get this product Paricalcitol solution, as need testing solution; Accurately measure and take the Paricalcitol reference substance stock solution in right amount, make about containing Paricalcitol 50ng in every 1ml with 50% ethanol quantitative dilution solution, as a contrast solution;

[0068] 2. Sensitivity solution: Accurately measure an appropriate amount of the reference substance solution, and quantitatively dilute it with 50% ethanol to make a solution containing about 5 ng of paricalcitol per 1 ml, as the sensitivity solution;

[0069] 3. System suitability solution: Accurately measure the appropriate amount of paricalcitol reference substance stock solution and impurity 20S, 7Z, 24R, 14R, 22Z reference substance stock solution respectively, and dilute with 50% ethanol to make each 1ml c...

Embodiment 2

[0076] Example 2 Simultaneous separation and analysis of paricalcitol and isomer impurities in paricalcitol injection

[0077] The preparation of the reference solution, the sensitivity solution and the system suitability solution is the same as the steps 1-3 of Example 1, and the separation, analysis and detection are carried out according to the chromatographic conditions in Table 3. The chromatogram results are as figure 2 As shown, the separation degree of each impurity is greater than 1.5.

[0078] Table 3. Chromatographic conditions

[0079]

Embodiment 3

[0080] Example 3 Simultaneous Separation and Analysis of Paricalcitol and Isomer Impurities in Paricalcitol Injection

[0081] The preparation of the reference solution, the sensitivity solution and the system suitability solution is the same as the steps 1-3 of Example 1, and the separation, analysis and detection are carried out according to the chromatographic conditions in Table 4. The chromatogram results are as image 3 As shown, the separation degree of each impurity is greater than 1.5.

[0082] Table 4. Chromatographic conditions

[0083]

[0084]

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Abstract

The invention belongs to the field of analysis chemistry, and particularly relates to a high performance liquid chromatography method for simultaneously separating and analyzing paricalcitol and isomer impurities in paricalcitol injection. The method is characterized in that a used chromatographic column uses octadecyl bonded silica gel as filling agents and uses methanol-water as a flowing phaseA and methanol as a flowing phase B for elution; the volume ratio of the flowing phase methanol-water is (20 to 30):(70 to 80); the method is used for simultaneously separating and analyzing the paricalcitol and isomer impurities in paricalcitol injection. The method can be used for better separating and analyzing the paricalcitol and isomer impurities 20S and / or impurities 24R and / or impurities 7Z and / or impurities 14R and / or impurities 22Z in the paricalcitol injection; the interference is avoided; the blank that the detection method is not provided by the existing quality standard or literature is made up; the method has the advantages of simplicity, high speed, high accuracy and the like; the technical support can be provided for the quality control of the paricalcitol injection.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to high performance liquid chromatography, a mobile phase and a high performance liquid chromatography for simultaneously separating and analyzing paricalcitol and isomer impurities in paricalcitol injection. Background technique [0002] Paricalcitol is a chemical substance with the molecular formula C27H44O3. Paricalcitol is a synthetic vitamin D analog with biological activity, which modifies the side chain (D2) and A ring (19-nor) of calcitriol, and is mainly used for the treatment of chronic kidney disease. [0003] Paricalcitol is a selective, third-generation vitamin D receptor activator developed by Abbott, which can selectively activate vitamin D receptor (VDR) and selectively up-regulate calcium-sensing calcium in the thyroid gland. sex receptor (CaSR), more efficiently inhibit the synthesis and secretion of PTH in patients with uremia, and less adverse rea...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/34G01N30/60
CPCG01N30/34G01N30/6052
Inventor 刘靖榆颜波赵静
Owner CHONGQING HUAPONT PHARMA
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