UV spectroscopy and least square matching for high throughput discrimination of taxanes in commercial formulations and compounded bags

Abstract

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−1). The RSD (%) of the precision was satisfactory (<3%). Finally, the suitability of the approach for the taxanes QC has been demonstrated under routine application.