Volume : 12, Issue : 01, January – 2025
Title:
DEVELOPMENT & VALIDATION OF RP-HPLC METHOD FOR ANALYTICAL EVALUATION OF TIOTROPIUM AND OLODATEROL IN PHARMACEUTICAL DOSAGE FORM
Authors :
Vagadani Sivasekar*, Dr.B. Sudhakar, Dr.K. Chaitanyaprasad, Dr.K. Shravankumar
Abstract :
A robust and reliable reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous determination of Tiotropium and Olodaterol in pharmaceutical dosage forms. The analysis was performed using a Waters Alliance 2695 HPLC system equipped with a PDA Detector 996 model. The separation was achieved on a Symmetry ODS C18 column (4.6 mm × 150 mm, 5 µm particle size) at a column temperature of 38ºC. The mobile phase consisted of Methanol and 0.1% Orthophosphoric acid in a 64:36 (v/v) ratio, with a flow rate of 1 mL/min. Detection was carried out at 224 nm, and the injection volume was optimized to 20 µL. The chromatographic conditions provided well-resolved peaks for Tiotropium and Olodaterol with retention times of 3.2 min and 5.1 min, respectively. The total analysis time was 7.0 minutes, making the method efficient for routine quality control analysis. The method was validated for various parameters, including linearity, accuracy, precision, specificity, and robustness. The linearity range for Tiotropium was 10-50 µg/mL and for Olodaterol, it was 5-25 µg/mL. The accuracy of the method was confirmed with recovery values between 98-102%, and precision was demonstrated with a relative standard deviation (RSD) of less than 2%. This RP-HPLC method offers a simple, rapid, and cost-effective solution for the simultaneous determination of Tiotropium and Olodaterol in pharmaceutical formulations, meeting the required validation criteria for analytical applications.
Keywords: Tiotropium and Olodaterol, RP-HPLC, Simultaneous Estimation, Pharmaceutical Dosage Forms, Waters HPLC.
Cite This Article:
Please cite this article in press Vagadani Sivasekar et al., Development & Validation Of RP-HPLC Method For Analytical Evaluation Of Tiotropium And Olodaterol In Pharmaceutical Dosage Form.,Indo Am. J. P. Sci, 2025; 12 (01).
Number of Downloads : 10
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