Rapid RP-HPLC Method Development and Validation of Tolvaptan in Bulk and Pharmaceutical Dosage Form for an Internal Standard

A simple, fast, precise and accurate RP-HPLC by internal standard method were developed and validated for the estimation of Tolvaptan as per ICH guidelines. Methanol: 0.2M phosphate buffer (70:30v/v) was used as the solvent. Sumatriptan was selected as an internal standard. The method was developed in Eclipse C₁₈ column (100 mm × 4.6 mm, 3.5 μm particle size). The method was found to be linear in the range of 5-100μg/ml with a correlation coefficient value of 0.999. The accuracy studies of RP-HPLC by internal standard method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range 99.01 to 100.7%. The % RSD is <2% which indicates the accuracy and precision of the method. The above method was a rapid tool for routine analysis of Tolvaptan in the bulk and in the pharmaceutical dosage form.