RP-HPLC法测定马来酸桂哌齐特片中有关物质的含量

目的:建立以反相高效液相色谱法测定马来酸桂哌齐特片中有关物质含量的方法。方法:色谱柱为Hypersil ODS2,流动相为0.05mol·L-1磷酸氢二钠溶液(用磷酸调pH至4.5)-乙腈(75∶25),检测波长为230nm,流速为1.0mL·min-1,进样量为20μL。结果:有关物质与主成分分离良好,3批样品中有关物质含量均为0.1%。结论:本方法操作简单、专属性强,可用于该制剂中有关物质的含量测定。     

HPLC法测定顺气化痰片的含量及含量均匀度

目的:建立顺气化痰片中马来酸氯苯那敏含量及含量均匀度检测方法.方法:采用高效液相色谱法,色谱柱:Kromasil 100-5 C18柱(250 mm×4.6 mm,5 μm).流动相:磷酸盐缓冲液-甲醇(70:30),检测波长:264 nm,流速:1.2 ml·min-1,柱温:30℃.结果:在2.14~107.00 μg·ml-1范围内呈良好的线性关系,r=0.999 3,平均回收率为99.81%,RSD=0.95%;其含量均匀度符合规定.结论:该方法操作简便、重复性好,可用于该制剂的质量控制.     

氨酚伪麻那敏片（Ⅱ）含量测定方法的改进

目的:建立改进的同时测定氨酚伪麻那敏片（Ⅱ）中对乙酰氨基酚、盐酸伪麻黄碱、马来酸氯苯那敏含量的HPLC法。方法:采用Inertsil C₁₈柱（150 mm×4.6 mm,5μm）,流动相:0.3%十二烷基硫酸钠溶液（含0.2%磷酸溶液）-乙腈（45:55）（用浓氨溶液调节pH至3.9）,流速为1.0 ml·min^-1,检测波长215 nm。结果:对乙酰氨基酚、盐酸伪麻黄碱、马来酸氯苯那敏分别在62～682,6.23～68.56,0.384～4.226μg·ml^-1浓度范围内与各自峰面积积分值呈良好的线性关系;平均回收率分别为99.47%（RSD=0.24%）,99.33%（RSD=0.34%）,99.18%（RSD=0.20%）（n=6）。结论:该方法准确、简便,可用于氨酚伪麻那敏片（Ⅱ）中3个组分的含量测定     

氨金黄敏颗粒的盐酸金刚烷胺薄层鉴别方法的修订

目的:修订氨金黄敏颗粒的盐酸金刚烷胺薄层色谱鉴别方法.方法:以盐酸金刚烷胺对照品为对照,采用硅胶G薄层板,以三氯甲烷-甲醇-丙酮-浓氨溶液(9:1.5:1:0.05)为展开剂,展开后晾干,喷以显色剂,可见光检视.结果:修订的盐酸金刚烷胺薄层鉴别方法,斑点清晰易辨,分离度和重现性均良好.结论:修订的薄层鉴别方法为国内5家...     

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...     

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.