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%. Top Keywords HPLC, Stability indicating, Validation, Dissolution, Assay. Top |