Method development and validation of taurolidine and heparin in tablet dosage form by using rp-hplc.

Abstract

A new, simple and accurate, precise RP-HPLC method was developed for simultaneous determination of Taurolidine and Heparin in bulk and in combined pharmaceutical dosage form. The separation of Taurolidine and Heparin was achieved within 8 minutes on an Agilent Zorbax (C18) (150mm x 4.6mm, 5µm) column using Methanol: Acetate Buffer pH-3.8 (24:76v/v) as the mobile phase. Detection was carried out using wavelength at 262nm. The method showed adequate sensitivity concerning linearity, accuracy and precision over the range 100-500μg/ml and 30-70μg/ml for Taurolidine and Heparin, respectively. Careful validation proved advantages of high sensitivity, accuracy, precision, selectivity, robust and suitability for quality control laboratories. The developed method was robust as the %RSD was within the range and without effecting system suitability parameters. The proposed method is suitable for simultaneous determination of Taurolidine and Heparin in bulk and pharmaceutical dosage form.