Rp-HPLC Method Development and Validation for The Quantification of Tiotropium Bromide and Formoterol Fumarate Dihydrate Rotacaps.

RP-HPLC method was method development and validation for the quantification of Tiotropium bromide and Formoterol fumarate dihydrate Rotacaps under different stability environments of acid, base, thermal, oxidation, and photolytic degradation. Separation was achieved on Kromacil C8, 5 µm, (150mm × 4.6 mm) column by using a mobile phase NH4H2PO4 Buffer (pH 3.0): Acetonitrile: Methanol (45:30:25) with Isocratic flow rate of 1.2 ml/min and detection was at 235 nm. The retention time of Tiotropium bromide was found to be 6.379 min and Formoterol fumarate was found to be 3.131 min. The method was linear and correlation coefficient was found to be 0.99985 for Tiotropium bromide and 0.99910 for Formoterol fumarate. The developed method was validated according to the ICH guidelines. The developed method was validated system suitability, linearity, Assay, accuracy, precision and robustness. Results of each parameter meet with this acceptance criterion. Hence, the method will be useful for routine quality control analysis.