New HPLC method for in vitro dissolution study of antihypertensive mixture amlodipine and perindopril using an experimental design

Anna Gumieniczek 1 , Paulina Mączka 1 , Tadeusz Inglot 1 , Rafał Pietraś 1 , Elżbieta Lewkut 1 , and Kinga Perczak 1
  • 1 Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

Abstract

A new HPLC method was developed for the determination of amlodipine and perindopril in their binary mixture as a part of a routine control of combined formulations. For the first time an HPLC method was used for an in vitro dissolution study of tablets containing the above drugs. The presented method was validated to meet official requirements and this validation included specificity, stability, linearity, precision and accuracy. Chromatography was carried out using a LiChrospher RP-18 column, a mixture containing acetonitrile and phosphate buffer of pH 3.0 (50:50, v/v) as mobile phase and UV detection at 225 nm. The dissolution test was performed using 900 mL of phosphate buffer at pH 5.5 containing 1% cetylpyridini chloride (CPC) at 37°C and 75 rpm, using the paddle method. Robustness procedure was done according to the plan defined by the Plackett-Burman design. The effects of acetonitrile content, pH of the buffer and flow rate of the mobile phase, column temperature, pH and CPC content in the dissolution medium as well as rotation speed of the paddle were considered. After that, both graphical and statistical methods were used for identification of significant and non-significant effects.

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