A method for detecting calcium / magnesium stearate content in a preparation by ion chromatography

By combining ion chromatography with microwave digestion and standard curve plotting, the matrix interference problem in the quantitative detection of calcium/magnesium stearate in pharmaceutical preparations has been solved, achieving high-sensitivity, low-cost, and accurate detection, which is suitable for multi-component preparations.

CN117783325BActive Publication Date: 2026-05-29HUBEI GUANGJI PHARMA +1
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Patent Information

Application Number
CN202311742899.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-12-18
Publication Date
2026-05-29
Estimated Expiration
2043-12-18

AI Technical Summary

Technical Problem

Existing technologies are insufficient for accurately quantifying the content of calcium/magnesium stearate in pharmaceutical formulations, especially in multi-component formulations where matrix interference is significant, operations are complex, and costs are high.

Method used

The method employs ion chromatography combined with microwave digestion, acid removal-resolution treatment, and standard curve plotting. The content of calcium/magnesium stearate is calculated by the response relationship of calcium/magnesium elements, which simplifies the sample pretreatment steps and improves the specificity of detection.

Benefits of technology

It achieves highly sensitive, low-cost, and accurate quantitative detection of calcium/magnesium stearate, suitable for multi-component formulations, and guides the consistency of formulation formulations.

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Abstract

The present application relates to the field of pharmaceutical excipient detection, in particular to a method for quantitatively detecting calcium stearate and magnesium stearate in preparations by ion chromatography. The present application draws the standard curves of calcium / magnesium ions and excipients calcium stearate / magnesium stearate respectively, obtains the slope ratio of the two, obtains the conversion coefficient of the content of calcium / magnesium ions in calcium stearate / magnesium stearate, so as to accurately detect the content of calcium stearate or magnesium stearate in preparations. The detection method has high sensitivity, strong specificity, high precision, strong accuracy, simple and fast operation, wide applicability, low detection cost, realizes the quantitative detection of common excipients calcium stearate / magnesium stearate in preparations, thereby effectively guiding the self-prepared preparations to be consistent with the reference preparation prescription.
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