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Method for detecting procalcipotriol, impurity C and impurity D in calcipotriol ointment

A technology of calcipotriol and detection method, which is applied in the field of analysis and detection, can solve problems such as the effective separation of unmentioned calcipotriol, and achieve the effect of ensuring safety and effectiveness

Active Publication Date: 2021-10-22
JIANGSU SEMPOLL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In the text of the Pharmacopoeia, there are controls on impurity C and impurity D under the inspection item, but there is no mention of procalcipotriol and its effective separation from impurity C and impurity D

Method used

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  • Method for detecting procalcipotriol, impurity C and impurity D in calcipotriol ointment
  • Method for detecting procalcipotriol, impurity C and impurity D in calcipotriol ointment
  • Method for detecting procalcipotriol, impurity C and impurity D in calcipotriol ointment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Determination according to high performance liquid chromatography (Chinese Pharmacopoeia 2020 edition general rule 0512).

[0045] Chromatographic conditions:

[0046] High-performance liquid chromatography is adopted, and the filler of the chromatographic column is octadecylsilane bonded silica gel; the column length of the chromatographic column is 250mm, the diameter is 4.6mm, and the filler particle size is 5μm;

[0047] The flow rate through the chromatographic column is 1.0 mL / min, the injection volume is 20 μL, and the column temperature is 30°C;

[0048] The detector used in the analysis and determination is selected from the ultraviolet detector, and the detection wavelength of the ultraviolet detector is 264nm;

[0049] Using isocratic elution, the mobile phase includes mobile phase A and mobile phase B, mobile phase A is water, mobile phase B is acetonitrile, and the volume ratio of mobile phase A and mobile phase B is 45:55.

[0050] Assay:

[0051] Solut...

Embodiment 2

[0052] Example 2 Detecting the system suitability solution test of procalcipotriol, impurity C and impurity D in calcipotriol ointment

[0053] Take the appropriate amount of reference substances such as impurity C, impurity D and calcipotriol, dissolve and dilute with mobile phase to make a mixed solution containing 0.005 mg of impurity C, 0.005 mg of impurity D and 1 mg of calcipotriol per 1 mL, shake well, As a system suitability solution. Precisely measure 50 μL, inject it into the liquid chromatograph, and record the chromatogram. The peaks of pre-calcipotriol, impurity C, calcipotriol and impurity D appear in sequence, and the separation between adjacent chromatographic peaks is not less than 1.5. The retention time of each component is as figure 1 As shown, the test results are as follows:

[0054] components Retention time (min) relative retention time Separation procalcipotriol 10.283 0.88 - Impurity C 10.780 0.92 1.60 Calcipotri...

Embodiment 3

[0056] Example 3 Quantitation limit test of procalcipotriol, impurity C and impurity D in a kind of calcipotriol ointment

[0057] Take the appropriate amount of impurity C, impurity D and calcipotriol reference substance respectively, place them in a volumetric flask, dissolve them with a diluent and make a solution containing 10 ng of impurity C, impurity D and calcipotriol per mL, and use The diluent was gradually diluted until the S / N was no less than 10.0, and the solution with this concentration was used as the limit of quantitation solution, and six parallel preparations were made. Precisely measure 50 μL of each solution, inject them into the liquid chromatograph respectively, and record the chromatograms. The test results are as follows:

[0058] name Quantitation limit solution (μg / mL) Concentration level (%) Impurity C 0.0024 0.04 Impurity D 0.0025 0.04 Calcipotriol 0.0025 0.04

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Abstract

The invention discloses a method for detecting procalcipotriol, an impurity C and an impurity D. According to the detection method, a high performance liquid chromatograph is adopted for detection, and the method comprises the following steps: (1) preparation of a solution: preparing a test solution; diluting the test solution by using a mixed solution of a mobile phase A and a mobile phase B according to the test solution to prepare a reference solution; (2) measuring the test solution and the reference solution, respectively injecting the test solution and the reference solution into a high performance liquid chromatograph, and recording chromatograms; (3) taking a proper amount of an impurity C, an impurity D and a calcipotriol reference substance, dissolving and diluting by using a mobile phase, and uniformly shaking to obtain a system applicable solution; and (4) measuring the system applicable solution, injecting the system applicable solution into a high performance liquid chromatograph, and recording a chromatogram. The method is good in precision, accurate, sensitive and reliable in result and wide in application range; meanwhile, the method is simple and easy to implement, low in cost and suitable for application and popularization.

Description

technical field [0001] The invention relates to the technical field of analysis and detection, in particular to a detection method for procalcipotriol, impurity C and impurity D in calcipotriol ointment. Background technique [0002] Psoriasis is an autoimmune disease with a high incidence rate, commonly known as "psoriasis". Its pathology is primarily epidermal proliferation and inflammation, characterized by accelerated proliferation and differentiation of keratinocytes, increased in situ autoreactive T cells, and angiogenesis and dilation. The psoriatic epidermis is in a state of hyperproliferation, and the homeostasis of the skin epidermis is maintained in an accelerated manner. The proliferation rate of psoriatic epidermis is 30 times that of normal epidermis. Due to the increase of cell density in the basal layer of the epidermis, when the density exceeds a certain threshold, the transiently amplified cells with rapid proliferation ability are pushed outwards, thereb...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/34G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/14G01N30/34G01N30/36G01N30/74
Inventor 刘永波蔡蓓蕾谈雨晴
Owner JIANGSU SEMPOLL PHARMA
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