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Method for determining content of rosuvastatin calcium and related substances thereof by employing HPLC (high performance liquid chromatography) method

A technology for rosuvastatin calcium and related substances, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of the gradient elution method, such as complicated isocratic elution, difficulty in popularization, high requirements on instruments, equipment and chromatographic columns, and the like, Achieving the effect of good separation, saving detection cost and easy operation

Active Publication Date: 2013-12-18
GUANGDONG XIANQIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Trivedi HK (Development and Validation of a stability-indicating RP-UPLC Method for Determination of Rosuvastatin and Related Substance in Pharmaceutical Dosage Form.Sci Pharm.2012Jun; 80(2):393-406.) uses ultra-high pressure liquid chromatography to detect Rosuvastatin The degradation products of vastatin calcium, on the one hand, the method has high requirements on equipment and chromatographic columns, and is difficult to popularize; on the other hand, the gradient elution method is more complicated than isocratic elution
Therefore, none of the currently available analytical methods have been reported to allow the simultaneous separation and quantification of all known degradation products of rosuvastatin calcium within chromatographic elution times using HPLC.

Method used

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  • Method for determining content of rosuvastatin calcium and related substances thereof by employing HPLC (high performance liquid chromatography) method
  • Method for determining content of rosuvastatin calcium and related substances thereof by employing HPLC (high performance liquid chromatography) method
  • Method for determining content of rosuvastatin calcium and related substances thereof by employing HPLC (high performance liquid chromatography) method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] ① Rosuvastatin Calcium Reference Substance Solution: Accurately weigh 25 mg of Rosuvastatin Calcium Reference Substance, put it in a 50ml volumetric flask, add 30ml of water, dissolve it by ultrasonic, add water to dilute to the mark, shake well, and get it;

[0050] ② Preparation of degradation products:

[0051] Photodegradation product stock solution: Weigh 25 mg of rosuvastatin calcium reference substance, put it in a 50ml volumetric flask, add 30ml of water, dissolve it by ultrasonic, dilute to the mark with water, shake well; measure 10ml of this solution, put it in a clean glass vial, Put the vial under a light device (light intensity is about 15000-25000 lx·hour) at 25°C for 2 hours, and adjust the light time if necessary to obtain an appropriate amount of photodegradation products PDP1 and PDP2. Transfer the illuminated solution to a 25ml volumetric flask, add 5ml of acetonitrile to shake, add water to dilute to the mark, and shake well.

[0052]Lactonization ...

Embodiment 2

[0077] Preparation of the testing solution: get rosuvastatin calcium (sample 2), and prepare according to the preparation method of the testing solution in 1. Chromatographic conditions

[0078] High performance liquid chromatography: Agilent

[0079] Chromatographic column: Agilent C18 (150mm×4.6mm, 5μm)

[0080] Mobile phase: methanol: water (containing 0.8% trifluoroacetic acid) = 55:45

[0081] Flow rate: 0.75mL / min

[0082] Detection wavelength: 242nm

[0083] Injection volume: 10μL

[0084] Column temperature: 40°C

[0085] Other conditions are with embodiment 1.

[0086] see results Figure 4 : Peaks 1-6 in the figure are the main peak of rosuvastatin calcium, the optical isomer peak of rosuvastatin calcium, and the oxidative degradation product ZD4522B 2 , Lactonization degradation product ZD4522 (3R, 5S). Under the above conditions, the peaks of rosuvastatin calcium and each product reached baseline separation, and the separation degrees from left to right we...

Embodiment 3

[0088] Preparation of the testing solution: get rosuvastatin calcium (sample 3), and prepare according to the preparation method of the testing solution in 1. Chromatographic conditions

[0089] High performance liquid chromatography: Agilent

[0090] Chromatographic column: Agilent C18 (150mm×4.6mm, 5μm)

[0091] Mobile phase: methanol: water (containing 0.1% trifluoroacetic acid) = 55:45

[0092] Flow rate: 0.75mL / min

[0093] Detection wavelength: 240nm

[0094] Injection volume: 10μL

[0095] Column temperature: 40°C

[0096] Other conditions are with embodiment 1.

[0097] see results Figure 5 : Peaks 1-6 in the figure are the main peak of rosuvastatin calcium and the oxidative degradation product ZD4522B 2 , lactonization degradation product ZD4522 (3R, 5S), photodegradation product ZD4522PDP1 and photodegradation product ZD4522PDP2. Under the above conditions, the peaks of rosuvastatin calcium and each product reached baseline separation, and the separation de...

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Abstract

The invention discloses a method for determining content of rosuvastatin calcium and related substances thereof by employing an HPLC (high performance liquid chromatography) method. By adopting the method, octadecylsilane chemically bonded silica is selected as a chromatographic column of a filler, and a mobile phase is formed by methanol and water (containing 0.1-0.8% of trifluoroacetic acid). The content of the rosuvastatin calcium and the related substances thereof can be accurately determined under a chromatographic condition, so that the quality of materials and preparation of the rosuvastatin calcium is well controlled.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a method for determining the content of rosuvastatin calcium and its related substances by HPLC. Background technique [0002] Rosuvastatin is a selective HMG-CoA reductase inhibitor that can regulate blood lipids. Usually exists in the form of its calcium salt, the molecular formula is C 44 h 54 CaF 2 N 6 o 12 S 2 , the chemical name is bis-(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]-pyrimidin-5-yl]( 3R,5S)-3,5-hydroxy-6-heptenoic acid] calcium salt. AstraZeneca's sales of rosuvastatin calcium in 2012 reached USD 6.253 billion, and the drug has a good market and application prospect. [0003] [0004] Rosuvastatin calcium has two chiral centers, is unstable in nature, and is prone to degradation, etc. Therefore, it is necessary to establish a determination method for its content and related substances to ensure the quality control of the f...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 李玲梅杜丽丽王学文邱思婕张志生张晓凤郑芳芳
Owner GUANGDONG XIANQIANG PHARMA
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