Rio Grande do Sul Technical and Scientifical Division, Brazilian Federal Police, 90160-093 Porto Alegre, RS, Brazil.
J Pharm Biomed Anal. 2012 Jan 25;58:7-11. doi: 10.1016/j.jpba.2011.09.005. Epub 2011 Sep 22.
The production of counterfeited drugs is a criminal problem that carries serious risks to public health in the worldwide. In Brazil, Viagra and Cialis are the most counterfeit medicines, being used to inhibit the phosphodiesterase type 5 (PDE-5), treating thus, problems related to erectile dysfunction. X-ray fluorescence (XRF) is a suitable technique to control the quality of new pharmaceutical formulations and distinguish between authentic and counterfeit tablets. XRF has advantageous features like multielemental capability, good detectivity, high precision, short analysis times, and is nondestructive, which makes it suitable to be extended to a great variety of samples. In this work, the inorganic fingerprinting chemical of forty-one commercial samples (Viagra, Cialis, Lazar, Libiden, Maxfil, Plenovit, Potent 75, Rigix, V-50, Vimax and Pramil) and fifty-six counterfeit samples (Viagra and Cialis) were obtained from XRF data. XRF presented an excellent analytical methodology for semi-quantitative determination of active ingredient (in case of sildenafil citrate that presents S in its structure) and excipients such as calcium phosphate, titanium oxide and iron oxide (P, Ca, Ti and Fe). The matrix data were allied to chemometric methods (Principal Component Analysis and Hierarchical Cluster Analysis) to classify the tablets investigated between authentic and counterfeit, grouping the samples into of seven groups: A, B, C, D and E (counterfeit group) and F and G (authentic group).
假冒药品的生产是一个全球性的犯罪问题，对公众健康构成严重威胁。在巴西，伟哥和希爱力是最假冒的药品，用于抑制磷酸二酯酶 5（PDE-5），从而治疗与勃起功能障碍相关的问题。X 射线荧光（XRF）是一种控制新药物制剂质量并区分真假片剂的合适技术。XRF 具有多元素能力、良好的检测性、高精度、短分析时间和非破坏性等优点，非常适合扩展到各种不同的样品。在这项工作中，从 XRF 数据中获得了四十一个商业样本（伟哥、希爱力、拉扎尔、利班德、马克斯菲特、普伦诺维特、波坦特 75、里吉克斯、V-50、威马和普拉米尔）和五十六个假冒样本（伟哥和希爱力）的无机指纹化学物质。XRF 提出了一种用于半定量测定活性成分（在其结构中存在 S 的情况下为枸橼酸西地那非）和赋形剂（如磷酸钙、二氧化钛和氧化铁（P、Ca、Ti 和 Fe））的出色分析方法。基质数据与化学计量学方法（主成分分析和层次聚类分析）相结合，用于将研究中的片剂分为真假两组，将样品分为七组：A、B、C、D 和 E（假冒组）和 F 和 G（真实组）。
