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To establish a atomic absorption spectroscopy (AAS) method for detecting calcium content in recombinant human coagulation factor Ⅷ for injection, and evaluate its uncertainty.
A calcium hollow cathode lamp light source was used. Air acetylene flame atomizer. Detection wavelength 422.7 nm. 8.9% lanthanum oxide solution was used as an ionization inhibitor. Conduct inspections on specificity, accuracy, precision, quantification limit, linearity and range, stability, etc. in accordance with the validation guidelines for drug quality standard analysis methods in Part 9101 of the 2020 edition of the Chinese Pharmacopoeia. The established method was applyed to detect the content of 6 batches of samples.
There was a good linear relationship between calcium element and absorbance in the concentration range of 0.0-5.0 μg·mL-1, with r=0.999 8. The detection line was 0.071 6 μg·mL-1; The quantification limit was 0.216 9 μg·mL-1. The recovery rate of the spiked sample was 100.8% to 103. 2%. The repeatability RSD was 0.64%, and the solution was stable within 8 hours. The content determination results of 6 batches of samples all complied with the regulations. The uncertainty assessment result was (117.12±4.82) μg·mL-1, k=2.
AAS method is established for the detection of calcium content in recombinant human coagulation factor Ⅷ for injection. This method has the advantages of high sensitivity, fast analysis speed, good repeatability, high accuracy, and cost savings. At the same time, the uncertainty of this method is evaluated, which can provide quantitative evaluation indicators for the quality control of this variety.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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