Development of an HPLC–UV–Vis Method for the Determination of Epirubicin Residues on Stainless-Steel Surfaces
Gözde Gülin İnan, İbrahim Daniş, Durişehvar Özer ÜnalAbstract
Background
Cross-contamination control is essential in pharmaceutical manufacturing for highly potent and cytotoxic active pharmaceutical ingredients used in oncology products. Epirubicin, an anthracycline antineoplastic agent, requires reliable residue monitoring after cleaning because residual carryover on shared manufacturing equipment may pose quality and safety risks.
Objective
This study aimed to develop a practical HPLC–UV–Vis method for epirubicin determination, evaluate its chromatographic performance using solution-based standards and quality-control samples, and apply the method to swab samples collected from contaminated stainless-steel surfaces following different cleaning procedures.
Methods
Chromatographic separation was achieved on a Poroshell 120 SB-C8 column using an isocratic mobile phase of acetonitrile and purified water containing 0.1% orthophosphoric acid (28:72, v/v) at 0.5 mL/min, with UV–Vis detection at 480 nm, within the visible region. Chromatographic performance was evaluated using solution-based standards and quality-control samples for selectivity, carryover, linearity, sensitivity, accuracy, precision, stability, and system suitability. AISI 304 matte stainless-steel plates were contaminated with epirubicin solution, subjected to different cleaning procedures, and sampled by swabbing. Surface recovery was assessed separately at a single spiking level.
Results
The method was linear over 20–1000 ng/mL. The LOQ was established at 20 ng/mL (S/N = 10.2). The single-level surface-recovery assessment yielded a recovery of 70.5%. Cleaning procedures including 2% sodium hydroxide resulted in no quantifiable parent epirubicin peak under the applied chromatographic conditions.
Conclusion
The developed HPLC–UV–Vis method showed suitable chromatographic performance for epirubicin determination under the investigated solution-based conditions and was applied to residue monitoring in swab samples collected from stainless-steel surfaces following cleaning. Because surface recovery was assessed at only one spiking level, the complete surface-sampling and extraction procedure was not comprehensively validated.
Highlights
The developed HPLC–UV–Vis method was applied to epirubicin residue monitoring in swab samples collected from stainless-steel surfaces, with no quantifiable parent epirubicin peak observed after sodium hydroxide-containing cleaning procedures.