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Method for determining content of dierucoyl phosphatidylcholine by high performance liquid chromatography

A technology of dierucoylphosphatidylcholine and high-performance liquid chromatography, which is applied in the field of instrument analysis, can solve the problems of unrecorded quality standards, and achieve the effects of appropriate peak time, high precision, and good separation effect

Active Publication Date: 2019-07-23
江苏东南纳米材料有限公司
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  • Description
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  • Application Information

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Problems solved by technology

Dierucoylphosphatidylcholine has been recorded in the database of inactive pharmaceutical ingredients (excipients) of the US Food and Drug Administration, but its quality standards have not yet been recorded in the Chinese Pharmacopoeia (CH.p2015), the United States Pharmacopoeia (USP4. 0), European Pharmacopoeia (EP 9.0)
At present, there is no method for the determination of dierucoylphosphatidylcholine

Method used

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  • Method for determining content of dierucoyl phosphatidylcholine by high performance liquid chromatography
  • Method for determining content of dierucoyl phosphatidylcholine by high performance liquid chromatography
  • Method for determining content of dierucoyl phosphatidylcholine by high performance liquid chromatography

Examples

Experimental program
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Effect test

Embodiment 1

[0030] Example 1 Non-buffer mobile phase system high performance liquid chromatography detection

[0031] The invention provides a high-performance liquid chromatography detection method for measuring dierucoylphosphatidylcholine, and the chromatographic conditions are:

[0032] Chromatographic column: using Gemini C18 column (250×4.6mm, 5μm)

[0033] Mobile phase: Phase A is a mixed solution of methanol and water with a volume ratio of 9:1. Phase B is a mixed solution of chloroform, methanol and water with a volume ratio of 15:10:1; the gradient elution of the liquid chromatograph is set, and the method is shown in the following table:

[0034] time (minutes) A(％) B(％) 0 70 30 30 0 100 30.1 70 30 40 70 30

[0035] Mobile phase flow rate: 1.0mL / min;

[0036] Column temperature: 40°C;

[0037] Injection volume: 10μL;

[0038] Detector spray chamber temperature: 40°C;

[0039] Detector evaporation chamber temperature: 40°C;

[0040...

Embodiment 2

[0047] Embodiment 2 buffer solution mobile phase system high performance liquid chromatography detection

[0048] The invention provides a high-performance liquid chromatography detection method for measuring dierucoylphosphatidylcholine, and the chromatographic conditions are:

[0049] Chromatographic column: using Gemini C18 column (250×4.6mm, 5μm)

[0050] Mobile phase: Phase A is a mixed solution of methanol and phosphate buffer with a volume ratio of 9:1, wherein the concentration of phosphate buffer is 0.5-0.8mol / L, and the pH value is 4.0-4.5. Phase B is a mixed solution of chloroform, methanol and phosphate buffer with a volume ratio of 15:10:1, wherein the concentration of phosphate buffer is 1mol / L, and the pH value is 4.0-4.5; the gradient of the liquid chromatograph is set For elution, see the table below for the method:

[0051] time (minutes) A(％) B(％) 0 70 30 30 0 100 30.1 70 30 40 70 30

[0052] Mobile phase flow rate: ...

Embodiment 3

[0069] In order to verify the feasibility and accuracy of the above-mentioned embodiment 2, a linear relationship test, a precision test, an accuracy test, and a stability test were carried out.

[0070] 1. Linear relationship test

[0071] (1) Take an appropriate amount of dierucoylphosphatidylcholine, dissolve and dilute it with methanol to make the concentration of dierucoylphosphatidylcholine 100, 150, 200, 250, 300 μg·mL -1 A series of linear solutions;

[0072] (2) Detect the above-mentioned linear solution according to the detection conditions of Example 1, and record the chromatogram. The evaporative light scattering detector is a general-purpose detector, and its response value has a double-logarithmic relationship with the particle mass (concentration). / mL) to perform linear regression on the natural logarithm, the linear equation is: Y=1.4948X-0.0296, r=0.999, and the linear range is 100~300μg·mL -1 , the detection limit is 50 μg·mL -1 , has a good linear relat...

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Abstract

The invention discloses a method for determining a content of dierucoyl phosphatidylcholine by high performance liquid chromatography. The chromatographic conditions are as follows: the chromatographic column is a C18 chromatographic column; the mobile phase is as follows: phase A is a mixed solution of methanol and phosphate buffer solution with a volume ratio of 9 to 1, and phase B is a mixed solution of trichloromethane, methanol and phosphate buffer solution with a volume ratio of 15 to 10 to 1; elution is carried out according to a certain gradient condition; high performance liquid chromatography is carried out by using an ELSD detector, and the content of the dierucyl phosphatidylcholine is determined. According to the method for determining the content of the dierucoyl phosphatidylcholine by the high performance liquid chromatography provided by the invention, the content of the dierucyl phosphatidylcholine can be accurately determined by one-time high-efficiency liquid phase detection, so that a good separation effect can be achieved with related substances; and the labor, the time and the solvent costs are saved.

Description

technical field [0001] The invention relates to a method for measuring the content of dierucoylphosphatidylcholine by high performance liquid chromatography, belonging to the technical field of instrument analysis. Background technique [0002] Dierucoylphosphatidylcholine is a synthetic phospholipid, and it is an important pharmaceutical excipient in liposome preparation - bupivacaine liposome. The quality research of synthetic phospholipids plays an important role in the quality and process evaluation of liposome preparations, which is directly related to the quality research of preparations. Dierucoylphosphatidylcholine has been recorded in the database of inactive pharmaceutical ingredients (excipients) of the US Food and Drug Administration, but its quality standards have not yet been recorded in the Chinese Pharmacopoeia (CH.p2015), the United States Pharmacopoeia (USP4. 0), European Pharmacopoeia (EP 9.0). At present, there is no method for the content determination...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N2030/027
Inventor 宗玺吉民郑巧王冬冬
Owner 江苏东南纳米材料有限公司
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