Abstract
Objective To investigate the compatibility between Compound Tujinpi Tincture and high-density polyethylene(HDPE)bottle for topical liquid medicine.Methods The content of benzoic acid and salicylic acid was determined by the high-performance liquid chromatography(HPLC)method,and the volume fraction of ethanol was determined by the capillary column method according to the general rule 0711 of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ).According to the Guidelines of Evaluating Compatibility Between Pharmaceutical Packaging and Pharmaceuticals,the accelerated test[placed at a temperature of(40±2)℃and a relative humidity of(90±10)%for 6 months],long-term test[placed at a temperature of(25±2)℃and a relative humidity of(60±10)%for 12 months],special requirements test[placed at a temperature of(25±2)℃and a relative humidity of(20±5)%for 6 months(low humidity);placed at a temperature of(25±2)℃and a relative humidity of(90±10)%for 6 months(high humidity)],and multiple open test were conducted to investigate the changes in the content of benzoic acid,salicylic acid,and the volume fraction of ethanol during the actual use of Compound Tujinpi Tincture packaged with HDPE bottles.Results The linear ranges of benzoic acid and salicylic acid were 0.102-1.812 µg and 0.050-0.906 µg(R2=0.999 9,n=5),respectively,the RSDs of precision,stability,and repeatability test results were all lower than 0.5%(n=6),and the average recoveries of benzoic acid and salicylic acid were 99.34%and 99.24%,with RSDs of 0.72%and 0.92%(n=6),respectively.Under the conditions of accelerated test,long-term test,and special requirements test(low humidity and high humidity),all three batches of samples were clear solutions ranging from yellow-brown to reddish-brown,with no precipitation,turbidity,or discoloration,and no precipitation of particles or blocky substances.In the three batches of samples,average content of benzoic acid and salicylic acid,and the average volume fraction of ethanol in the accelerated test were 120.95-121.27 mg/mL,60.30-61.45 mg/mL,and 78.49%-79.49%,with RSDs<2.0%(n=18),those in the long-term test were 121.06-121.89 mg/mL,60.49-61.81 mg/mL,and 79.40%-79.70%,with RSDs<2.0%(n=18),those in the special requirements test(low humidity)were 121.64-121.89 mg/mL,60.55-61.88 mg/mL,and 79.23%-80.05%,with RSDs<2.0%(n=18),those in the special requirements test(high humidity)were 121.11-122.99 mg/mL,60.51-61.88 mg/mL,and 79.45%-80.41%,with RSDs<2.0%(n=18).The results of the multiple open test showed that the average content of benzoic acid and salicylic acid,and the average volume fraction of ethanol in samples were 121.86-123.90 mg/mL,60.60-62.08 mg/mL,and 79.74%-80.57%,with RSDs<2.0%(n=9).Conclusion The established HPLC method has accurate results,good precision and repeatability,which can be used for the determination of benzoic acid and salicylic acid in Compound Tujinpi Tincture.The compatibility between external liquid medicinal HDPE bottles and Compound Tujinpi Tincture is good,and the packaging can ensure the stable quality of Compound Tujinpi Tincture.关键词
复方土槿皮酊/高密度聚乙烯瓶/相容性/苯甲酸/水杨酸/乙醇Key words
Compound Tujinpi Tincture/high-density polyethylene bottles/compatibility/benzoic acid/salicylic acid/ethanol分类
医药卫生
