Monday , 22 April 2024

A Novel Analytical Method Development and Validation of Tiotropium Bromide and Formoterol Fumarate Pharmaceutical Dosage Forms by using RP-HPLC Method

S. Priyanka, M. Anuradha, Kavita Waghray
Department of Pharmacy, University College of Technology, Osmania University,Hyderabad-500007, Telangana, India

High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Tiotropium Bromide and Formoterol Fumarate was done by RP-HPLC Method. Separation was achieved under optimized chromatographic condition on stationary phase Inertsil C18 column (4.6 x 150mm, 5mm), the mobile phase consisting of Methanol : Phosphate Buffer (pH) in the ratio of 70:30 % v/v and pH was adjusted using orthophosphoric acid an isocratic elution was achieved at a flow rate 1.0 ml/min at an ambient temperature. The detection was carried out using UV detector at 260 nm. The solutions were chromatographed at a constant flow rate of 1 ml/min. Calibration curves were linear with correlation coefficient not more than 0.999 over a concentration range of 100 to 500 mg/ml of Tiotropium Bromide and 1 to 5mg/ml of Formoterol Fumarate respectively. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Tiotropium Bromide and Formoterol Fumarate. LOD and LOQ were found within limits. The results obtained on the validation parameters met ICH and USP requirements. It inferred the method found to be simple, accurate, specific, precise, linear and rugged. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.
Keywords: Inertsil C18, Tiotropium bromide and Formoterol fumarate, RP-HPLC

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