Abstract
This work is intended to thrive a stability indicating Ultra performance liquid chromatographic method for the estimation of Telmisatam (TLM) and Hydrochlorothiazide (HCTZ) and degradation products pharmaceutical dosage forms. Separation was carried out on Zorbax Eclipse XDB C-18(50 x 2.1 mm, 1.7 µm) column using a gradient method. Mobile phase A is 10mM KH2PO4 having 1% (v/v) of trimethylamine and mobile phase B is acetonitrile used in this work. 0.5 mL/ minute is the flow of rate and at 271nm noticed wave length is monitored. Method development trails were carried out on six different columns. For specificity, limit of quantification, limit of detection, linearity, accuracy, method precision, robustness and stability this method is validated. Correlation coefficient of the impurities is more than 0.99. Stability indicating method confirmed that there were no interference of all impurities of TLM and HCTZ. Hence, developed LC method was stability indicating and well applied for drug product stability study as well as to quality monitoring.
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