ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF TOLVAPTAN IN API FORM AND ITS MARKETED PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
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ABSTRACT
A simple, rapid, specific, and accurate reverse phase high performance liquid chromatographic method has been developed for the validation of Tolvaptan in bulk as well as in marketed pharmaceutical dosage form. This separation was performed on a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5μm column with Acetonitrile, Methanol and 0.1% OPA in the ratio of 60:30:10 as mobile phase at a flow rate of 1.0 mL min−1 with UV detection at 235 nm; the constant column temperature was Ambient. The runtime under these chromatographic conditions was less than 6.0 min. The retention time of Tolvaptan was found to be 2.570min. The calibration plot was linear over the concentration range of 6–14 μg mL−1 with limits of detection and quantification values of 0.8 and 0.24ng mL−1 respectively. The mean % assay of marketed formulation was found to be 99.79%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%. The developed method is simple, precise, specific, accurate and rapid, making it suitable for the estimation of Tolvaptan in bulk and marketed pharmaceutical dosage form dosage form.
Key words:
Tolvaptan, RP-HPLC, Validation, Accuracy, Precision, Robustness, ICH Guidelines.
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https://pubchem.ncbi.nlm.nih.gov/compound/RTolvaptan
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