在这项工作中,首次使用自动溶出系统(dissoBOT)进行溶出测试。测定对乙酰氨基酚(PA)和双氯芬酸钠(DS)的disoBOT的残留(CO),它们是活性药物成分(API)。最初,通过定义检测限(LOD)进行PA和DS测定的UV-VIS分光光度法的部分方法验证,定量限(LOQ),准确度,和精度。两种API的LOD和LOQ均小于0.01mg/L。确定的线性浓度范围为PA为1.00mg/L至30.00mg/L,DS为0.50mg/L至3.50mg/L(相关系数的平方均大于0.9990,质量系数均小于1.00%)。通过计算已知浓度的标准溶液的回收率(Re)来评估该方法的准确性。两种原料药的方法被认为是准确的(PA和DS的平均Re分别为99.81%和101.43%,分别)。通过计算相对标准偏差(RSD)评价精密度。PA和DS的方法被认为是精确的,由于PA的RSD值为0.13%,DS为0.38%。在由dissoBOT系统执行的两个清洁循环中洗涤介质的体积(V),以及介质分配V,建立,其中培养基分配V符合美国药典要求。DISSOBOT系统的CO,使用自来水作为洗涤介质,被确定为两种API都低于1.00%。V为2mL的采样站的一个清洁循环的CO值在1.24-1.54%的范围内,对于5mL的V,在0.78-0.93%的范围内,并且对于10mL的V在0.27-0.36%的范围内。此外,DISSOBOT的CO,当使用两个清洁循环时,采样站(每个V为10mL)减少(CO<0.20%)。最后,DISSOBOT成功用于溶出度PA和DS表。
In this work, an automated dissolution system (dissoBOT) was used for dissolution testing for the first time. Carry-over (CO) of the dissoBOT was determined for paracetamol (PA) and diclofenac sodium (DS), which are active pharmaceutical ingredients (APIs). Initially, partial method validation of the UV-VIS spectrophotometry method for PA and DS determination was performed by defining the limit of detection (LOD), the limit of quantification (LOQ), linear concentration range, accuracy, and precision. The LODs and LOQs were less than 0.01 mg/L for both APIs. The determined linear concentration ranges were from 1.00 mg/L to 30.00 mg/L for PA and from 0.50 mg/L to 3.50 mg/L for DS (the square of the correlation coefficient was greater than 0.9990, and the quality coefficient was less than 1.00 % for both APIs). The accuracy of the method was evaluated by calculating the recovery (Re) of the solutions of standards with known concentrations. The method for both APIs was deemed to be accurate (the average Re for PA and DS were 99.81 % and 101.43 %, respectively). Precision was evaluated by calculating the relative standard deviation (RSD). The method for PA and DS was deemed to be precise, as the RSD value for PA was 0.13 %, and for DS was 0.38 %. The volume (V) of the washing medium in both cleaning cycles performed by the dissoBOT system, as well as the medium dispensing V, were established, where the medium dispensing V was in accordance with the United States Pharmacopeia requirements. The CO of the dissoBOT system, using tap water as the washing medium, was determined to be less than 1.00 % for both APIs. The CO values for one cleaning cycle of the sampling station with a V of 2 mL was in the range of 1.24-1.54 %, for V of 5 mL was in the range of 0.78-0.93 %, and for V of 10 mL was in the range of 0.27-0.36 %. In addition, the CO of the dissoBOT, when employing two cleaning cycles of the sampling station (each V of 10 mL) was reduced (CO <0.20 %). Finally, the dissoBOT was successfully employed for the dissolution PA and DS tables.