Mon, 20 Nov 2017

A Novel validated RP-HPLC method for the estimation of Liraglutide in bulk and Parenteral Dosage form

S. Susena*1, K. Vanitha Prakash1, T.Radika1, R.Tejaswini1,E.Manasa1

1. SSJ College of Pharmacy, V.N. Pally, Gandipet, Hyderabad-500075(India).

Department: Pharmaceutical Analysis & Quality assurances)


ABSTRACT

A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the estimation of Liraglutide in bulk and Parenteral Dosage form. The proposed method is based on the separation of drugs in reversed-phase mode using Waters HPLC 22695 model, Inertsil ODS column (250 x 4.6 mm, 5µm particle size).The optimum mobile phase consisted of methanol: phosphate buffer in the ratio of 85:15 v/v(Phosphate buffer pH 5.5) was selected as a mobile phase, flow rate of 1.0 ml/min and UV detection was set at 246 nm. The retention time was 3.25.The method was validated according to ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the concentration range of 20-80 μg/ml . The percentage RSD for precision and accuracy of the method was found to be less than 2%. The proposed method can be successfully applied in the quality control of bulk and pharmaceutical dosage forms.


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