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Research Journal of Pharmacy and Technology
Year : 2016, Volume : 9, Issue : 8
First page : ( 1177) Last page : ( 1182)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2016.00225.0

Stability Indicating Assay Method Development and Validation of Naratriptan Hydrochloride By RP-HPLC

Sai Vijay M, Guptha D. Viswanath, Krishna B S Muddu, Dr. Vasantharaju S G*

Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India

*Corresponding Author E-mail: sg.vasanthraj@manipal.edu

Online published on 12 January, 2017.

Abstract

Analysis was performed using Gracesmart C18 column (250 × 4.5mm; 5μm). Isocratic mode of separation was followed using mobile phase which contains acetonitrile and phosphate buffer (pH adjusted to 4.0 by using ortho phosphoric acid) in proportion of 20: 80 v/v. The developed method employs use of UV detector with detection wavelength of 225 nm, volume of injection was 20 μl and employing flow rate of 1ml/min. The Rt of the drug under study was found to be 6.0 ± 0.3mins. Method was precise, accurate, reproducible, linear and robust. The method was linear between 0.1 μg/ml to 25 μg/ml with r2 of 0.9991. The method would be applicable for assay of tablet dosage from, stability and dissolution of marketed Naratriptan hydrochloride tablets. The % assay for tablets using the proposed method was found to be 100.17. The % RSD from system and method precision were 0.48 and 0.79 respectively. Accuracy was found to be 100.5%.

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Keywords

HPLC, Stability indicating, Validation, Dissolution, Assay.

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