Hôpital européen Georges Pompidou (HEGP), Service Pharmacie (AP-HP), 75015 Paris, France.
Hôpital européen Georges Pompidou (HEGP), Service Pharmacie (AP-HP), 75015 Paris, France.
Eur J Pharm Sci. 2018 Oct 15;123:143-152. doi: 10.1016/j.ejps.2018.07.047. Epub 2018 Jul 23.
The need for high-throughput quality control of pharmaceuticals after compounding is often required before the treatment of the patients. Ultra-fast analysis using flow injection analysis coupled to UV spectroscopy and least square matching was assessed for the simultaneous quantification and identification of three therapeutic taxanes after dilution in physiological saline (cabazitaxel, docetaxel, and paclitaxel). In-depth preliminary analysis of the zero and first order UV spectra of the taxanes using principal component analysis (PCA) allowed us focusing on relevant spectral range with very low formulation influence. Least square-matching algorithm available on basic HPLC software was applied to these spectra yielding very high match scores (>999) with significant difference (P < 0.0001). The approach was qualitatively assessed through specificity and sensitivity which were excellent for the three taxanes (100%, n = 378), irrespective of their formulation. In terms of quantification, satisfactory linearity and accuracy were achieved for each of the taxanes according to their therapeutic range (0.05 to 1.02 mg·mL). The RSD (%) of the precision was satisfactory (<3%). Finally, the suitability of the approach for the taxanes QC has been demonstrated under routine application.
在给患者治疗之前，通常需要对配制后的药物进行高通量质量控制。本研究采用流注射分析结合紫外光谱和最小二乘匹配法，对三种治疗性紫杉烷类药物（卡巴他赛、多西他赛和紫杉醇）在生理盐水中稀释后的同时定量和鉴定进行了超快速分析。使用主成分分析（PCA）对紫杉烷类药物的零阶和一阶紫外光谱进行深入的初步分析，使我们能够将重点放在受制剂影响非常小的相关光谱范围内。基本 HPLC 软件上的最小二乘匹配算法可用于这些光谱，得到的匹配分数非常高（>999），且差异具有统计学意义（P < 0.0001）。通过特异性和灵敏度对该方法进行了定性评估，三种紫杉烷类药物（100%，n = 378）的特异性和灵敏度均非常出色，无论其制剂如何。在定量方面，根据治疗范围（0.05 至 1.02 mg·mL），每种紫杉烷类药物均实现了令人满意的线性和准确度。精密度的 RSD（%）也令人满意（<3%）。最后，该方法已在常规应用中证明了其在紫杉烷类药物 QC 中的适用性。
