Volume No. :   7

Issue No. :  1

Year :  2017

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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



Address:   K. Vijaya Sri*, S. Sruthi, M.A. Madhuri
Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, (Affiliated to Osmania University) Maisammaguda, Secunderabad-500 014,
*Corresponding Author
DOI No: 10.5958/2231-5675.2017.00007.2

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.
KEYWORDS:
Tolvaptan, RP-HPLC method, internal standard, Development, Validation and Pharmaceutical formulation.
Cite:
K. Vijaya Sri, S. Sruthi, M.A. Madhuri. Rapid RP-HPLC Method Development and Validation of Tolvaptan in Bulk and Pharmaceutical Dosage Form for an Internal Standard. Asian J. Pharm. Ana. 2017; 7(1): 36-40.
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