Analytical Method Development and Validation of Tolvaptan in Bulk and Tablet Dosage Form by RP-HPLC
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2013, Vol 2, Issue 4
Abstract
A new, simple, accurate, precise, robust, specific, sensitive and rapid reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of TOLVAPTAN in pharmaceutical dosage forms. A Nucleosil C18 with mobile phase containing 0.01M sodium dihydrogen phosphate and acetonitrile in the ratio of 60:40 was used. The flow rate was 0.6 ml / min and wavelength was monitored at 269 nm. Chromatogram showed the main peak at a retention time of 3.055 min. The developed method was validated according to ICH guidelines and validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. The linearity was found to be in the range of 25 to 150 mcg / ml. respectively. Recovery of Tolvaptan was found to be in the range of 99.74-99.87% %.The system precision and method precision was found to be within limits with % RSD of 0.773 and 0.024% .The developed method was found to be cost effective and was successfully employed for the determination of the same in various formulations.
Authors and Affiliations
Prathyusha B
Keywords
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