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

• Autorzy: Anna Gumieniczek , Paulina Mączka , Tadeusz Inglot , Rafał Pietraś , Elżbieta Lewkut , Kinga Perczak
• Języki publikacji: EN

Abstrakty

EN

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. [...]

Słowa kluczowe

EN

HPLC; Experimental Design; Dissolution study; Amlodipine; Perindopril

• Czasopismo: Open Chemistry
• Rocznik: 2013
• Tom: 11
• Numer: 5
• Strony: 717-724

Daty

wydano

2013-05-01

online

2013-02-27

Twórcy

autor

Anna Gumieniczek

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland,

autor

Paulina Mączka

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

autor

Tadeusz Inglot

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

autor

Rafał Pietraś

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

autor

Elżbieta Lewkut

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

autor

Kinga Perczak

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

Bibliografia

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Identyfikatory

DOI

10.2478/s11532-013-0201-z