Development and Validation of RP-HPLC Method for the Simultaneous Determination of Trimethoprim, Sulfadimidine Sodium and Tylosin Tartrate in injectable solution formulation

A simple, robust and reliable reversed phase HPLC method was developed and validated for the simultaneous determination of Trimethoprim (TMP), Sulfadimidine sodium (SDMS) and Tylosin tartrate (TYT) in Nuroprim® injectable solution formulation. The desired separation was achieved on XBridge C18 column (150 ï‚´ 4.6 mm i.d., 5m) at room temperature. The optimized mobile phase consisted of a binary solvent mixture of acetonitrile and aqueous triethylamine (TEA) solution adjusted to pH 5.7 by acetic acid. The mobile phase flow rate was fixed at 1.0 ml/min and the analytes were monitored at 287 nm using photodiode array detector. The effects of the chromatographic conditions on peaks capacity factor, USP tailing factor, column efficiency and resolution were systematically optimized. The method was validated as per International Conference of Harmonization (ICH) and United States Pharmacopeia (USP) guidelines and found to be adequate for the routine quantitative determination of TMP, SDMS and TYT in commercially available Nuroprim® injectable solution dosage form.