Development and validation of a sensitive and robust chiral method for (R)-propylene oxide: From chiral gas chromatography to chiral liquid chromatography with pre-column derivatization

•A direct chiral GC method was developed and validated for (R)-propylene oxide.•Method robustness issue was uncovered due to GC column variability.•A better chiral HPLC method was developed and validated on a cellulose-based column.•Same chiral columns from different vendors could be leveraged for m...

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Bibliographic Details
Published in:Journal of Chromatography Open 2024-05, Vol.5, p.100141, Article 100141
Main Authors: He, Brian Lingfeng, Kubin, Michelle, Shi, Yueer, Kleintop, Brent
Format: Article
Language:English
Subjects:
Chiral gas chromatography
Chiral HPLC
Enantioseparation
Pre-column derivatization
Propylene oxide
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Summary:•A direct chiral GC method was developed and validated for (R)-propylene oxide.•Method robustness issue was uncovered due to GC column variability.•A better chiral HPLC method was developed and validated on a cellulose-based column.•Same chiral columns from different vendors could be leveraged for method optimization. Propylene oxide (PO) is an important chemical commodity and a chiral building block to prepare pharmaceutical compounds. It is crucial to develop a sensitive and robust chiral method that can be used to assess the enantiomeric purity of PO and safeguard the quality and safety of pharmaceutical products in commercial quality control (QC) laboratories. A chiral gas chromatography (GC) method based on direct enantioseparation of PO enantiomers on a 50-meter Chiraldex™ A-TA open capillary column was successfully developed for determination of enantiomeric impurity (S)-PO in (R)-PO. However, it was revealed that the chiral GC method lacked adequate robustness for routine use. Consequently, a chiral high-performance liquid chromatography (HPLC) method was developed through pre-column derivatization of PO with 2-naphthalenethiol followed by enantioseparation on a Lux Cellulose-1 (250 mm × 4.6 mm, 5 µm) column. The chiral HPLC method has been demonstrated excellent specificity, sensitivity, accuracy and robustness through method validation and robustness evaluation, thus establishing its suitability for routine use in QC laboratories. Chiral analysis of (R)-propylene oxide by chiral chromatography. [Display omitted]
ISSN:2772-3917
2772-3917
DOI:10.1016/j.jcoa.2024.100141