HPLC法测定氨酚伪麻那敏分散片中的对氨基酚

目的:建立高效液相色谱法测定氨酚伪麻那敏分散片中对氨基酚的含量.方法:采用ZORBAX E-clipse XDB-C8(4.6 mm×250 mm,5μm);流动相为磷酸盐缓冲液-甲醇(95:5);流速1.0 mL·min-1;检测波长230 nm;柱温30℃;进样量10μL.结果:对氨基酚和相邻色谱峰分离度良好,对氨...     

HPLC法测定感冒灵胶囊5种有效成分的含量

目的建立测定感冒灵胶囊中对乙酰氨基酚、绿原酸、咖啡因、马来酸氯苯那敏和蒙花苷的含量分析方法。方法采用高效液相色谱(HPLC)法,色谱柱为Waters XBridge C 18(4.6 mm×250 mm,5μm);流动相为甲醇-4%冰醋酸(三乙胺调节pH值至3.0);梯度洗脱;绿原酸和蒙花苷检测波长为334 nm,对乙酰氨基酚、马来酸氯苯那敏和咖啡因检测波长为260 nm;流速为1.0 mL·min-1;柱温为35℃。结果对乙酰氨基酚、绿原酸、咖啡因、马来酸氯苯那敏及蒙花苷5个成分在测定的范围内均表现出良好的线性关系(r≥0.9996),平均回收率为98.45%~100.12%。结论该方法操作快速简便,分离效果好,灵敏度高,重现性良好,为测定感冒灵胶囊主成分的含量提供了一种快速高效可靠的方法。     

Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online

Patient safety risks associated with the online purchase of medications, especially in case of ophthalmic preparations, are significant. Our study aimed to carry out quality assessment of dorzolamide hydrochloride (DZA) and timolol maleate (TIM) eye drops preserved with benzalkonium chloride (BAC) via online test purchases.Three samples were purchased online, while control preparations were acquired through authorized national drug supply chain. Our method was based on the International Pharmaceutical Federation (FIP) Inspection Checklist and integrated the evaluation of packaging and labelling. Sterility was established according to the European Pharmacopoeia (Ph. Eur.), while qualitative and quantitative quality was assessed with high-performance liquid chromatographic (HPLC) analysis.Several signs of falsification were recognized upon visual inspection of the online samples. All the products were clear, colourless, slightly viscous solutions. They were free from visible contaminants. The samples were sterile as no evidence of microbial growth was found. A quick and inexpensive HPLC analysis, optimized by the authors showed that active ingredients and the preservative deviated significantly (p < 0,05) with more than 10% from the values stated on the labels for at least one component (DZA: 99.3–113.1%, TIM: 112.8–139.2%, BAC: 82.4–97.7%).Development of comprehensive and reliable quality assessment methods are vital to increase public safety of pharmaceutical products sold online. A complex approach, integrating visual inspection, labelling assessment, microbiological analysis coupled with qualitative and quantitative methods provide a most reliable method. Due to its limited feasibility and cost-effectiveness, raising public awareness and limiting illegal online sellers should be the primary approaches to protect patients from substandard and falsified medicinal products sold via the internet. Particularly important for health professionals to understand this market and its public health concern, and to raise patient awareness of the risks associated with uncontrolled online purchase of medication.