Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TOLVAPTAN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

B.Prathyusha*, B.Shirisha, N.Ramathilagam, J.Priya, Chandra K Sekhar

ABSTRACT

A new simple accurate and suitable reverse phase high performance liquid chromatographic method was developed for the determination of Tolvaptan in bulk and tablet dosage form. The separation was eluted on a Nucleosil C18 column (100 mm x 4.6 mm; 5μ) using a mobile phase mixture of sodium phosphate buffer pH 5.5±0.1 and Acetonitrile in a ratio of 60:40 v/v at a flow rate of 0.6ml/min. The detection was made at 269 nm. The retention times were 3.05±0.1min for Tolvaptan. Calibration curve was linear over the concentration range of 7.5- 42.5μg/ml for Tolvaptan. The propose method was validated as per the ICH guidelines parameters like Linearity, specificity, precision, accuracy, robustness and ruggedness. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.

Keywords: Method development and validation, Tolvaptan, Tablets, C18 column, RPHPLC.