Development and Validation of Stability Indicating Method for the Simultaneous Estimation of Tamsulosin HCl and Tolterodine Tartrate in Pharmaceutical Dosage form Dr. Joshi H. V.*, Dr. Shah U. A., Dr. Patel J. K., Patel T. R. Department of Quality Assurance, Nootan Pharmacy College, Sakalchand Patel University, Kamana Cross Road, Visnagar-384315, Gujarat, India *Corresponding Author E-mail: hirakjoshi@gmail.com
Online published on 31 December, 2019. Abstract A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Tamsulosin HCl and Tolterodine tartrate in their combined dosage form has been developed. The separation was achieved by LC-20 AT C18 (250mm x 4.6 mm x 2.6 μm) column and Buffer (pH 4.0): Methanol (60: 40) as mobile phase, at a flow rate of 1ml/min. Detection was carried out at 305 nm. Retention time of Tamsulosin HCl and Tolterodine tartrate were found to be 3.440 min and 5.693 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Tamsulosin HCl 2–6 μg/ml and for Tolterodine tartrate 20–60 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Tamsulosin HCl and Tolterodine tartrate in their combined dosage form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in alkaline degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form. Top Keywords Tamsulosin HCl, Tolterodine tartrate, Stability indicating RP-HPLC Method, Validation. Top |