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

• Authors: Anna Gumieniczek , Paulina Mączka , Tadeusz Inglot , Rafał Pietraś , Elżbieta Lewkut , Kinga Perczak
• Languages of publication: EN

Abstracts

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. [...]

Keywords

EN

HPLC; Experimental Design; Dissolution study; Amlodipine; Perindopril

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2013
• Volume: 11
• Issue: 5
• Pages: 717-724

Dates

published

1 - 5 - 2013

online

27 - 2 - 2013

Contributors

author

Anna Gumieniczek

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

author

Paulina Mączka

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

author

Tadeusz Inglot

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

author

Rafał Pietraś

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

author

Elżbieta Lewkut

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

author

Kinga Perczak

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

References

• [1] I. Gavras, T. Rosenthal, Curr. Hypertens. Rep. 6, 267 (2004) http://dx.doi.org/10.1007/s11906-004-0020-x[Crossref]
• [2] C. Graffner, Eur. J. Pharm. Sci. 29, 288 (2006) http://dx.doi.org/10.1016/j.ejps.2006.05.003[Crossref]
• [3] V. Bhaskara Raju, A. Lakshmana Rao, International Journal of Chemical Sciences 9, 1290 (2011)
• [4] J. Prajapati et al., Int. J. PharmTech. Res. 3, 801 (2011)
• [5] S.P. Nayak, S. Pillai, Res. J. Pharm. Technol. 4, 735 (2011)
• [6] F. Dong, Stat. Sinica 3, 209 (1993)
• [7] Y. Vander Heyden et al., J. Pharm. Biomed. Anal. 24, 723 (2001) http://dx.doi.org/10.1016/S0731-7085(00)00529-X[Crossref]
• [8] P.H. Tran et al., Expert Opin. Drug Del. 7, 647 (2010) http://dx.doi.org/10.1517/17425241003645910[Crossref]

Identifiers

DOI

10.2478/s11532-013-0201-z