A New Stability-Indicating and Validated RP-HPLC Method for the Estimation of Liraglutide in Bulk and Pharmaceutical Dosage Forms

Abstract

A stability-indicating RP-HPLC method was developed and validated for the estimation of
Liraglutide in bulk and pharmaceutical dosage forms. Shiseido C18 (250 mm x 4.6 mm I.D.,
5 µm particle size) column was used as stationary phase with mobile phase consisting
methanol+acetonitrile (80:20): phosphate buffer (pH 3.0 adjusted with ortho phosphoric
acid) in the ratio of 75:25, v/v. The flow rate was maintained at 1.2 ml/min and effluents
were monitored at 245 nm. The retention time was found to be 2.837 minutes. The forced
degradation studies were performed as per ICH guidelines under acidic, alkali, oxidative,
thermal, photostability and neutral conditions. The drug peak was well resolved from the
peaks of degraded products. From the degradation studies it is evident that the drug
showed instability under acidic, alkali, oxidative, thermal, photostability and neutral
conditions. The linearity of the method was observed in the concentration range of 10-60
µg/ml with the number of theoretical plates & tailing factor being 5550 & 1.17 respectively
with a correlation coefficient of 0.999. The percentage assay of Liraglutide was found to be
99.66%. The method was validated for its accuracy, precision and system suitability. The
results obtained in the study were within the limits of ICH guidelines and hence this method
can be used for the estimation of Liraglutide in bulk and pharmaceutical dosage forms.