A New Highly Effective UPLC Method for the Simultaneous Estimation of Taurolidine and Heparin in Bulk and Pharmaceutical Dosage Form

AbstractA novel, rapid, precise, and highly sensitive Ultra-Performance Liquid Chromatography (UPLC)method with Photodiode Array (PDA) detection was developed and validated for thesimultaneous estimation of Taurolidine and Heparin in bulk and pharmaceutical dosage forms(Defencath). Chromatographic separation was achieved on an X-Bridge C18 column (50 mm ×4.6 mm, 3.5 µm) using an isocratic mobile phase consisting of Acetonitrile and AmmoniumFormate buffer (pH 2.5 adjusted with OPA) in a 50:50 (v/v) ratio at a flow rate of 0.2 mL/min.The detection wavelength was set at the isosbestic point of 249 nm. Retention times were 0.834min for Taurolidine and 1.975 min for Heparin, resulting in a total run time of 3.0 minutes.Linearity was established in the range of 6.75–40.50 µg/mL for Taurolidine (R² = 0.9996) and25.00–150.00 µg/mL for Heparin (R² = 0.9997). The mean percentage recoveries were 99.9–100.6% and 99.7–101.0% for Taurolidine and Heparin, respectively. Forced degradation studiesunder acid, alkali, peroxide, reduction, thermal, photolytic, and hydrolytic conditionsdemonstrated that the method is stability-indicating, with no interfering peaks from degradationproducts or excipients. The developed method is suitable for routine quality control and assayevaluation in pharmaceutical industries.