Ultra Sensitive UPLC Method Development and Validation for the Simultaneous Estimation of Tamsulosin Hydrochloride and Tolterodine Tartrate in Bulk and Pharmaceutical Dosage Form

Abstract

A rapid, sensitive and accurate ultra-performance reversed phase liquid chromatographic method was developed for the simultaneous determination of tamsulosin and tolterodine in pure form and pharmaceutical preparation. The developed UPLC method is superior to conventional HPLC with respect to speed, resolution, solvent consumption and cost. The separation was carried out on RP C18 nucleosil (1.7 µm, 5 cm x 2 mm) using an isocratic mode in eluting Tamsulosin and Tolterodine at 1.54 min and 2.43 min respectively with a mobile phase composed of acetonitrile and 0.025N potassium phosphate buffer pH 3.50 (60%:40%), respectively. Chromatographic run time was 5 min with a flow rate 0.5 ml/min and UV detection at 220 nm. The linearity for tamsulosin and tolterodine were in the range of 2-20 µg/mL for both drugs, showed excellent recoveries for bulk and tablet dosage form with a very low LOD of 4.29 and 0.59 ng/mL for tamsulosin and tolterodine, respectively. The method has been validated for linearity, accuracy, precision, specificity, and limit of detection, limit of Quantification, robustness, and ruggedness. The method which was developed was validated as per the ICH guidelines. Finally, the method was compared statistically with reference methods indicating that there is no significant difference between them in respect of precision and accuracy.