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Liquid chromium picolinate10/7/2023 ![]() Measure respectively above-mentioned need testing solution and reference substance solution, sample size 10 μ l, flow velocity 1ml/min, 30 ℃ of column temperatures, Parallel testing 2 times, records chromatogram, then the content with each impurity of calculated by peak area by external standard method. According to the invention, chromium picolinate, the starting material and intermediates for synthesis of chromium picolinate, and the generated impurities can realize complete separation, the peak shape and the degree of separation are good, and the sensitivity and accuracy are high, so that the method can satisfy analysis of the limit of impurities in the chromium picolinate bulk drug. The method includes: adopting an ultraviolet detector equipped liquid chromatograph, taking octyl bonded silica gel as a packed column, employing an acetic acid water solution-acetonitrile mixed solution with a mass concentration of 0.5%-2.0% as a mobile phase, with the wavelength of the ultraviolet detector being 200-300nm adding 50mg of a chromium picolinate sample into 60ml of methanol to undergo ultrasonic dissolving, adding methanol to perform dilution to 100ml, shaking the mixture uniformly, then conducting filtration by a 0.45-micrometer filter membrane to obtain a test solution adding methanol into 1ml of the test solution to perform dilution to 100ml, shaking the mixture uniformly, then conducting filtration by a 0.45micrometer filter membrane to obtain a self reference solution and measuring the test solution and the reference solution, carrying out sample introduction by 10 microliters respectively, recording the chromatogram, and then calculating the content of all impurities according to peak area by an external standard method. ![]() The invention discloses a high performance liquid chromatography method for detecting the limit of impurities in a chromium picolinate bulk drug. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) Filing date Publication date Application filed by FUGE PHARMACEUTICAL Co Ltd HEBEI PROVINCE filed Critical FUGE PHARMACEUTICAL Co Ltd HEBEI PROVINCE Priority to CN201410058793.2A priority Critical patent/CN104090055B/en Publication of CN104090055A publication Critical patent/CN104090055A/en Application granted granted Critical Publication of CN104090055B publication Critical patent/CN104090055B/en Status Active legal-status Critical Current Anticipated expiration legal-status Critical Links Original Assignee FUGE PHARMACEUTICAL Co Ltd HEBEI PROVINCE Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)įUGE PHARMACEUTICAL Co Ltd HEBEI PROVINCE ( en Inventor 岳振路 Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.) Granted Application number CN201410058793.2A Other languages Chinese ( zh) Google Patents High performance liquid chromatography method for detecting limit of impurities in chromium picolinate bulk drugĭownload PDF Info Publication number CN104090055A CN104090055A CN201410058793.2A CN201410058793A CN104090055A CN 104090055 A CN104090055 A CN 104090055A CN 201410058793 A CN201410058793 A CN 201410058793A CN 104090055 A CN104090055 A CN 104090055A Authority CN China Prior art keywords chromium picolinate solution impurities bulk drug methyl alcohol Prior art date Legal status (The legal status is an assumption and is not a legal conclusion. ![]() Google Patents CN104090055A - High performance liquid chromatography method for detecting limit of impurities in chromium picolinate bulk drug
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