Detection method for related substances of salbutamol sulfate solution used for inhalation
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A technology of salbutamol sulfate and detection method, applied in the detection field, can solve problems such as less impurities
Inactive Publication Date: 2019-12-31
SICHUAN PURITY PHARM CO LTD
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[0004] However, in the current pharmacopoeias of many countries, such as EP9.8, USP42, and ChP2015, "Salbutamol Sulfate Solution for Inhalation" is not included; in BP2019, although "Salbutamol Sulfate Solution for Inhalation" is included, it can be Fewer impurities detected
Method used
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Embodiment 1
[0069] Solution preparation:
[0070] Diluent: mobile phase A.
[0071] Test solution: Take 1 stick of this product, accurately measure 1ml, put it in a 10ml measuring bottle, dilute to the mark with diluent, shake well, and you will get it.
[0072] System suitability solution: Accurately weigh an appropriate amount of 5-hydroxysalbutamol, impurity J, and salbutamol sulfate reference substance, dissolve and dilute with a diluent to make each 1ml contain 0.2 mg of salbutamol and 0.4 μg of impurities (including 5-hydroxysalbutamol) respectively mixed solution, as a system suitability solution.
[0073] (1) Condition 1: Implement the chromatographic method of the import registration standard JX20160145
[0074] The method is confirmed, the chromatographic conditions are shown in Table 1, and the test results are shown in figure 1 .
[0077] The chromatographic method of JX20160145 was co...
Embodiment 2
[0104] Embodiment 2 is to the detection of crude drug
[0105] Adopt the chromatographic conditions in table 6:
[0106] Table 6
[0107]
[0108] Image 6 It can be seen that the purity of the raw material drug is very high and hardly contains any impurities.
[0109] Methodology validation report:
[0110] Table 7 Summary of verification items and results
[0111]
[0112]
[0113] After the verification of the analytical method, the specificity of the method is good, the blank excipients do not interfere with the detection of impurities, the separation of each impurity and the main peak is good, the detection limit and quantification limit of each impurity meet the determination requirements and the linearity of each impurity is good; the method is proved by fine-tuning the chromatographic conditions Good durability.
[0114] In summary, the detection method of the present invention is better than the chromatographic conditions in the existing import registrat...
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Abstract
The invention discloses a detection method for related substances of salbutamol sulfate solution used for inhalation. A high performance liquid chromatography method is adopted for performing qualitative or / and quantitative detection on the related substances of the salbutamol sulfate solution used for inhalation, and liquid chromatography detection conditions comprise that a C8 chromatographic column is adopted, mobile phases comprise a mobile phase A and a mobile phase B, wherein the mobile phase A is phosphate buffer solution, the mobile phase B is mixed solution of acetonitrile and methanol with the volume ratio of (40-65):(60-35), and the mobile phases adopt a gradient elution method. By adopting the detection method disclosed by the invention, a main drug and other related impuritiesin the salbutamol sulfate solution used for inhalation can be effectively detetected, and the detection method has specificity and stability indication capability and also can detect a new impurity 5-hydroxy salbutamol at the same time.
Description
technical field [0001] The invention relates to the field of detection methods, in particular to a detection method for related substances of salbutamol sulfate solution for inhalation. Background technique [0002] Salbutamol sulfate is a selective beta 2 - Adrenergic receptor agonists, which are fast-acting (within 5 minutes), short-acting (4 to 6 hours) bronchodilators for reversible airway obstruction. At therapeutic doses, acts on beta on bronchial smooth muscle 2 - Adrenergic receptors, which are particularly suitable for use in the treatment and prevention of asthma exacerbations due to their rapid onset of action. [0003] Nebulized treatment medicine can directly reach the affected part, so it is widely used in respiratory department. Nowadays, salbutamol sulfate is mostly used by aerosol inhalation, so patients often use salbutamol sulfate solution preparation for inhalation. Compared with other treatment methods , more convenient to use, faster onset, the marke...
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