This blog post focuses on a vastly improved method for the analysis of Paclitaxel, approved as Taxol by the National Cancer Institute (NCI), for the treatment of ovarian cancer. An earlier method for the analysis of paclitaxel and related compounds by reversed-phase (RP) HPLC was published by both the United States Pharmacopeia (USP) and the Chinese Pharmacopoeia (CP). These methods each required over 70 min. Although other RP-HPLC assays for paclitaxel are reported in the literature, all of them are also relatively long (15 to 35 min).
Application Brief 119, Rapid Separation of Paclitaxel and Related Compounds in Paclitaxel Injection, (downloadable PDF) describes a rapid (<6 min) and efficient UHPLC method to separate paclitaxel and related compounds using a Thermo Scientific Acclaim Rapid Separation Liquid Chromatography (RSLC) column with a water/acetonitrile/methanol gradient and UV detection at 227 nm. The improved UHPLC method achieves a baseline separation with resolution values greater than those required in US and Chinese Pharmacopeia methods.
With this improved UHPLC method, it was found that the methanol/acetonitrile/water ternary gradient dramatically reduced the analysis time by an order of magnitude and meets USP and CP requirements for peak resolution and peak area reproducibility.
Further Reading Suggestions on Our Pharma Solutions
- Drug discovery analytical applications for drug design, drug metabolism and pharmacokinetics (DMPK) lab, natural products, and metabolomics.
- Drug development analytical solutions for pre-clinical drug development; clinical trials for drug development; chemistry, manufacturing, and control for drug development; and regulatory compliance for pharmaceuticals.
- Drug manufacturing analytical solutions for QA/QC, process analytics, and regulatory compliance.
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