5.3 中间精密度试验：照“5.2”项下方法制备供试品溶液，由不同的分

5.3 中间精密度试验：照“5.2”项下方法制备供试品溶液，由不同的分析人员使用不同的仪器进行测定，分别进样6次，计算含量的RSD值。
6 准确度（加样回收率实验）：供试品取半量，同时按测定结果的80%、100%、120%加入对照品溶液（每一浓度3份），进行加样回收率试验，回收率应为95.0%~105.0%，9份的RSD应不得过2.0%。
7 溶液稳定性试验：分别进行对照品溶液与供试品溶液的室温稳定性考察与冰箱冷藏的稳定性考察，为对照品溶液的保存时间及供试品测定时间提供依据。
8 色谱条件的耐用性试验：考察不同柱温（±5℃）、不同流速（±10%）、不同色谱柱、不同仪器、不同检测波长对测定结果的影响及系统适用性情况（拖尾因子、分离度、理论塔板数）的影响，确定色谱条件的可接受范围。
9 限度确定：结合不同生产日期样品的测定结果（10批）及其中3批样品的稳定性试验结果确定含量限度。

結果 (英文) 1:

5.3 intermediate precision test: according to "5.2", a method to provide test solution, by different analysts use different instruments to determine sample respectively 6 times, calculate RSD values for content.6 accuracy (plus recovery experiment): take half dose to be tested, and according to the results of 80%, 100%, 120%, by adding a control solution (concentration 3 each), spotting the recovery test recovery should be 95.0%~105.0%,9 the RSD may not be too 2%.7 solution stability test: separate reference solution for sample stability at room temperature and refrigerate the stability, as the reference solution saves time and provide evidence for determination of Elution times.8 chromatographic conditions for durability test: to determine the column temperature (± 5 ℃), different flow rates (± 10%), different chromatographic columns, different equipment, different wavelengths to detect impact and applicability of the system of results (the tailing factor, resolution, number of theoretical plates) the influence of chromatographic conditions are determined the acceptable range.9 determine the limits: combined results of samples with different production dates (10) and its stability test results determine the concentration limits of 3 batches of samples.

結果 (英文) 3:

The 5.3 intermediate precision test: according to "5.2" under the method for the preparation of test sample solution, by different analysts using different instruments were measured, respectively, into the sample for 6 times, the content of RSD value calculation.
6 accuracy (recovery test): the sample of half amount, at the same time, according to the determination results of 80%, 100%, 120% add the reference solution (3 copies of each concentration), for recovery of the added sample test, recovery rate should be 95.0%~105.0%, 9 copies of the RSD should be no more than 2%.
7 tests of solution stability were investigated: a reference solution and the stability of the test solution at room temperature stability and a refrigerator,As the reference solution to save time and sample provides the basis for the determination of time. The durability test of
8 chromatographic conditions: the effects of different column temperature (- 5 DEG C), different flow rates (+ 10%), different chromatographic column, different instruments, different detection wavelengths on determination results and application effects of the system of the situation (tailing factor, the degree of separation, the number of theoretical plates) to determine the effects of chromatographic conditions, the range of acceptance.
9 the limit: the determination results of samples of different production date (the 10 batch) and the stability of the test results of 3 batches of sample to determine the content limit.