Degradation kinetics of Aliskiren hemifumarate under stress conditions and its determination in tablets by stability indicating HPLC method
Maha Said Ahmed Abd El-Tawab
Cairo University, Egypt
: J Diagnos Tech Biomed Anal
Abstract
Aliskiren hemifumarate (ALS) is the first member of a new class of non-peptide renin inhibitors, used as anti-hypertensive agent. Degradation of ALS under alkaline conditions was studied in order to investigate the degradation kinetics of the drug. The analysis of the degraded samples was performed by an isocratic stability indicating liquid chromatographic method. Good separation of ALS from its alkaline degradation product was obtained using Kromasil C18 column (150 x 4.6 mm, 5 µm) at room temperature. The mobile phase was composed of acetonitrile: phosphate buffer (50 mM adjusted to pH 3.5 with o-phosphoric acid) (40: 60, v/v) at a flow rate of 1 ml/min. UV detection was carried out at 229 nm. Linearity was obtained over the concentration range 1.5 – 300 µg/ml. ICH guidelines were adopted for method validation. The method showed high sensitivity, good accuracy and precision. The proposed method was applied to the drug determination in pharmaceutical formulation. The kinetics parameters, such as order of reaction, rate constants and half-life (t1/2) were determined. The degradation of ALS followed pseudo-first order reaction and the degradation rate constant was found to increase by increasing Na OH concentration (up to 1.5 N) and temperature (up to 90°C). The obtained results confirm the reliability of the chromatographic method for the kinetic investigation of the alkaline degradation of ALS and for determining the intact drug in presence of its alkaline degradation product.
Biography
Maha Said Ahmed Abd El-Tawab has graduated from the Faculty of Pharmacy, Cairo University in 2008 with a grade of excellent with honour degree and completed her Master degree in Pharmaceutical Sciences (Pharmaceutical Chemistry) from the same faculty. She is currently an assistant lecturer at the Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University. She has contributed to a conference at Cairo University in 2013 and published a paper in the same year concerning the analysis of some cardiovascular drugs. Also, she is serving as a reviewer at a reputed journal in analytical chemistry.
maha.abdeltawab@pharma.cu.edu.g
