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Method for detecting content of element impurities in atorvastatin calcium
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A technology for atorvastatin calcium and element impurities, which is applied in the field of analysis and detection, can solve the problems of inability to detect multiple impurity elements at the same time, low detection efficiency, etc., and achieve the effects of saving detection time, high sensitivity and reducing sensitization effect.
Pending Publication Date: 2022-08-02
HANGZHOU XINBOSI BIOMEDICAL CO LTD
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However, there are few reports on the detection methods of atorvastatin calcium element impurities, and the existing conventional element detection methods generally cannot detect multiple impurity elements at the same time, and the detection efficiency is low
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Embodiment 1
[0044] A kind of detection method of element impurity content in atorvastatin calcium, described method comprises the following steps:
[0047] ) to prepare blank solution: take an appropriate amount of diluent in a 50ml PMP volumetric flask, add 500μl of 2μg / ml mixed internal standard solution, diluent to volume, and shake well.
[0049] Precisely measure 2000 μL of 100 μg / mL mixed internal standard solution (Bi, Ge, In, Li 6 , Lu, Rh, Sc, Tb mixed internal standard) in a 100 mL PMP volumetric flask, dilute to volume with water, and shake well (concentration: 2 μg / mL).
[0050] ) to prepare a linear standard solution:
[0051] ①Multi-element intermediate stock solution: Precisely measure 250 μL of As, Cd, Co, Hg, Li, Ni, Pb, V multi-element standard solution in a 50 mL PMP volumetric flask, dilute the...
[0068] Determination method: Inject the linear standard solution 1, linear standard solution 2 and diluent in Example 1 online, in which the diluent is continuously injected for 12 injections, and the other injections are injected 1 injection, record the response value, and calculate the detection according to the following formula limit of quantification (LOD) and limit of quantification (LOQ).
[0069]
[0070]
[0071] In the formula: SD: the standard deviation of the response value of each element (n=12);
[0072] K: The X-axis of each element is the concentration value, the response value CPS of the element to be tested is the Y-axis, and the slope of the standard curve obtained by making the curve.
[0073] The detection limit test results are shown in Table 5, and the quantification limit test results are shown in Table 6. See the typical diagram Figure 7-Figure...
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Abstract
The invention provides a method for detecting the content of element impurities in an atorvastatincalciumbulk drug. The method comprises the following steps: preparing a linear standard solution of each element impurity, preparing an internal standard solution, preparing a to-be-detected sample solution, and detecting through an inductively coupled plasmamassspectrometer. According to the method, a sample pretreatment mode is optimized, so that the trouble that the sample needs to be digested is overcome. The method for simultaneously detecting the contents of the eight impurity elements in the atorvastatincalcium is designed by optimizing parameters of an instrument and screening a proper internal standard solution, and the method not only has high accuracy, but also greatly improves the detection efficiency.
Description
technical field [0001] The invention relates to the technical field of analysis and detection, in particular to a detection method for determining the impurity content of 8 elements in atorvastatincalcium by inductively coupled plasmamass spectrometry (ICP-MS). Background technique [0002] Atorvastatin calcium tablets (trade name Lipitor) is a potent lipid-lowering drug launched by Pfizer in 1997, which can be used for the treatment of hypercholesterolemia and coronary heart disease or coronary heart disease and other risk diseases complicated with hypercholesterolemia or Patients with mixed dyslipidemia have been widely used in the treatment of hyperlipidemia, especially hypercholesterolemia, because of their strong lipid-lowering effect and small adverse reactions. In addition, atorvastatin calcium also has various non-lipid-regulating effects such as stabilizing plaque, improving endothelial function, inhibiting inflammation, and reducing thrombosis, which can reduce t...
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