T/HIFSA 0007-2024 The determination of cirindinolactone in Noni extract

Scope

Scope: This standard specifies the liquid chromatography method for determining the content of cycloartane in noni enzyme. This standard is applicable to the determination of cycloartane in noni enzyme. The detection limit of cycloartane in this method is 0.5mg/kg, and the quantification limit is 2.0mg/kg. Main technical content: 4. Principle: The sample is centrifuged to obtain a supernatant, which is diluted and quantified using a liquid chromatography UV detector. The retention time is used for qualitative analysis, and the external standard method is used for quantitative analysis. 5. Reagents and materials: Unless otherwise specified, all reagents used in this method are of analytical grade, and the water used is Class I water as specified in GB/T6682. Reagent acetonitrile (C2H3N): chromatographically pure. Phosphoric acid (H3P04): chromatographically pure. Preparation of 0.1% phosphoric acid solution: Accurately pipette 1mL of phosphoric acid and dilute to 1000mL with water. Standard samples: Genisteinic acid standard (C18H24O12, CAS No.: 25368-11-0): purity ≥98.0%; or standard materials certified by the state and awarded with a standard material certificate. Deacetylgenisteinic acid standard (C16H22O11, CAS No.: 18842-99-4): purity ≥98.0%; or standard materials certified by the state and awarded with a standard material certificate. Preparation of standard solution: A mixed standard solution of genisteinic acid and deacetylgenisteinic acid is prepared by accurately weighing 5mg (to an accuracy of 0.0001g) of genisteinic acid standard and 25mg (to an accuracy of 0.0001g) of deacetylgenisteinic acid standard, dissolving them in water, and diluting to 10mL. Store at 4℃ for 6 months. Materials: - Chromatography column: C18 column. - Water-phase microporous filter membrane: 0.22μm. - Plastic centrifuge tubes: 50mL. 6. Instruments and equipment: - High-performance liquid chromatograph equipped with a UV detector. - Centrifuge. - Analytical

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