RP HPLC Method Development and Validation for Quantitative Estimation of Tiotropium Bromide and Oldaterol

A simple and selective LC method is described for the determination of Tiotropium Bromide and Olodaterol dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 50 volumes of acetonitrile and 50 volumes of Triethyl-amine buffer with detection of 225 nm. Linearity was observed in the range 30-70 μg /ml for Tiotropium Bromide (r2 =0.9987) and 40-80 μg/ml for Olodaterol (r2 =0.9977) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing % RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.