Detection method of dotegravir sodium tablets

CN119198952APending Publication Date: 2024-12-27ANHUI BIOCHEM BIO PHARMA
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Patent Information

Application Number
CN202411355311.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-09-27
Publication Date
2024-12-27

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Abstract

The invention discloses a detection method of a dotegravir sodium tablet. The detection method comprises the following steps: determining the content of the dotegravir sodium tablet, determining related substances, and determining a dissolution rate or a wide pH aqueous solution dissolution curve. The determination method adopts a high performance liquid chromatography method. Compared with the prior art, the detection method has the advantages that the sensitivity is higher, the detection wavelength is 258nm, the sample determination is faster and the sensitivity is higher under the condition, the efficient separation and quantitative determination of a plurality of related substances can be realized, the specificity is good, the separation degree is high, the sensitivity is excellent, the drug quality can be better detected, and the method is suitable for popularization and application. The effectiveness and the safety of the medicine are ensured; the content determination accuracy is higher, and the precision is better; the method is beneficial to large-scale wide-pH water system dissolution curve detection of multiple media and multiple time points, and has the characteristics of high speed, short time, good durability and the like.
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