Fri, 20 Apr 2018

liquid chromatography; sofosbuvir, velpatasvir, forced degradation studies.

Shivarudregowda GS*, Jose Gnana Babu C, Tamizh Mani T.

1.Bharathi College of Pharmacy, Bharathi Nagara, K.M. Doddi, Maddur Taluk,

2.Mandya District, Karnataka, India


ABSTRACT

A simple, specific, accurate, precise and sensitive RP- HPLC method has been developed for the rapid estimation of Alogliptin in bulk and its formulations. The chromatographic separation was carried on Phenomenex Gemini-NX-5 µm C18(2) 110A, LC Column 250 x 4.6 mm, using Acetonitrile:1-octasulphonoic acid (0.005mM) at pH-5 [60:40] (v/v) as mobile phase, at a flow rate of 1.0 ml/min.  The detection was carried out at 220 nm and drug eluted with a retention time of 3.48 min. Beer’s law was obeyed in the concentration range of 2-10μg/ml with correlation coefficient 0.9995. The method has been validated according to ICH guidelines for specificity, linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. The method was found to be specific, accurate, and precise, robust, rugged and sensitive. The developed method was good linearity, novel, rapid for the estimation of Alogliptin in bulk and tablets dosage form. Thus it can be employed for the routine analysis.

Keywords: Alogliptin, RP-HPLC, Validation.


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