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Method for determining content of compound by utilizing relative correction factor

A technology of relative correction factors and compounds, applied in measurement devices, instruments, scientific instruments, etc., can solve problems such as time-consuming, and achieve accurate results and simple methods.

Active Publication Date: 2010-06-16
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Danish Leo Pharmaceutical Co., Ltd.’s method for determining the labeled content of calcipotriol preparations is time-consuming, and the extracted sample solution needs to be kept at 75°C for 2 hours before it can be determined by high-performance liquid chromatography.

Method used

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  • Method for determining content of compound by utilizing relative correction factor
  • Method for determining content of compound by utilizing relative correction factor
  • Method for determining content of compound by utilizing relative correction factor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The mensuration (chromatographic condition 1) of calcipotriol relative correction factor before embodiment 1

[0049] 1) Preparation of standard solution

[0050] Take calcipotriol standard 10mg, put it in a 50ml measuring bottle, add 10ml of methanol to dissolve, add extraction solvent to dilute to the mark, shake well, take 10.0ml and put it in 100ml, add extraction solvent to dilute to the mark, shake well, take appropriate amount respectively Put it in a vial, seal it with a cap, put it in a water bath at 75°C for 30, 60, and 120 minutes, take it out, and cool it down quickly.

[0051] 2) Take the above-mentioned standard solution kept in the constant temperature water bath at 75°C at different time points, and inject 20 μl of it according to the chromatographic condition 1 respectively. Record the chromatogram, measure the pre-calcipotriol peak area and the calcipotriol peak area respectively, and calculate the relative correction factor. The measurement results a...

Embodiment 2

[0059] The mensuration of calcipotriol relative correction factor (chromatographic condition 2) before embodiment 2

[0060] 1) Preparation of standard solution

[0061] Take calcipotriol standard 10mg, put it in a 50ml measuring bottle, add 10ml of methanol to dissolve, add extraction solvent to dilute to the mark, shake well, take 10.0ml and put it in 100ml, add extraction solvent to dilute to the mark, shake well, take appropriate amount respectively Put it in a vial, seal it with a cap, put it in a water bath at 75°C for 30, 60, and 120 minutes, take it out, and cool it down quickly.

[0062] 2) Take the above-mentioned standard solution kept at different time points in the constant temperature water bath at 75°C, and inject 20 μl of it according to the chromatographic condition 2 respectively. Record the chromatogram, measure the calcipotriol peak area and the calcipotriol peak area respectively, and calculate the relative correction factor. The measurement results are s...

Embodiment 3

[0067] Example 3 Calcipotriol Ointment Marked Content Determination

[0068] 1. Test samples:

[0069] Samples 1 to 3: calcipotriol ointment (batch numbers: 20080301, 20080302, 20080303, manufacturer: Chongqing Huabang Pharmaceutical Co., Ltd.).

[0070] Sample 4: Calcipotriol ointment (Lot No.: EA8695, Leo Pharmaceuticals Ltd., Ireland).

[0071] Ointment blank base (batch number: 20080201, manufacturer: Chongqing Huabang Pharmaceutical Co., Ltd.).

[0072] Calcipotriol standard substance: Weigh two parts and measure twice for each part.

[0073] Samples: Weigh two parts of each sample, and measure each sample once.

[0074] 2. Determination of labeled content of calcipotriol ointment by relative correction factor method

[0075] (1) Chromatographic conditions: same as chromatographic conditions 1

[0076] (2) Preparation of internal standard stock solution Take 20 mg of methyltestosterone, put it in a 100ml measuring bottle, add extraction solvent to dissolve and dilute...

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Abstract

The invention relates to a method for determining the content of a compound easy to generate configuration conversion in a solution by utilizing high-efficiency liquid chromatography, comprising the following steps of: measuring the peak areas of a converted isomer and an unconverted isomer of a sample solution of the compound to be measured, multiplying the peak area of the converted isomer by arelative correction factor C and then adding the peak area of the unconverted isomer so that the marked content of the compound to be measured is calculated according to the result. When used for measuring the marked content of calcipotriol in a calcipotriol solvent, the method obtains a satisfactory result. The method has the advantages of simplicity, practicality and accurate result.

Description

technical field [0001] The invention relates to a method for determining the content of a compound by using a relative correction factor, in particular to a method for measuring the content of a compound that is prone to configuration transformation by using high performance liquid chromatography. Background technique [0002] Many biologically active substances have one or more chiral centers, and there are many isomers. Even a single isomer compound, under certain conditions, such as preparing a solution or at an appropriate temperature, the single isomer can be transformed, especially when the solution is heated or cooled. [0003] Especially when the drug is made into a non-solid preparation, because the drug is in a non-solid matrix or in a solution, configuration transformation is likely to occur for a drug with a chiral center, and under different conditions (such as different solvents or different temperatures), The degree of conversion varies. This brings greater ...

Claims

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Application Information

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IPC IPC(8): G01N30/86
Inventor 王平
Owner CHONGQING HUAPONT PHARMA
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