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Asian Journal of Pharmaceutical Analysis
Year : 2017, Volume : 7, Issue : 1
First page : ( 36) Last page : ( 40)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2017.00007.2

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

Vijaya Sri K.*, Sruthi S., Madhuri M.A.

Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, (Affiliated to Osmania University) Maisammaguda, Secunderabad-500 014

*Corresponding Author E-mail: vijayasree_2002@yahoo.co.in

Online published on 18 September, 2017.

Abstract

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.

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Keywords

Tolvaptan, RP-HPLC method, internal standard, Development, Validation and Pharmaceutical formulation.

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