TY - JOUR
T1 - Quantitative determination of propranolol by ultraviolet HPLC in human plasma
AU - Salman, S. A.B.
AU - Sulaiman, S. A.
AU - Ismail, Z.
AU - Gan, S. H.
N1 - Funding Information:
Financial support from Universiti Sains Malaysia short-term grant (grant no: 304/PPSP/6131398). The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
Funding Information:
We would like to thank Pharmaniaga RAZA Manufacturing Berhad®, Malaysia for the gift of PRN and OXP standards and Universiti Sains Malaysia for the financial support.
PY - 2010/3
Y1 - 2010/3
N2 - Many previous published methods for the quantitative determination of propranolol (PRN) in human plasma have poor recoveries and were not validated according to the FDA guideline. The aim of this study is to develop a simple HPLC method for detecting PRN in human plasma and to validate it so that it can be applied to a clinical study. Chromatographic separation was achieved using a mixture of a mobile phase consisting of 160 ml water, 180 ml methanol, 70 ml acetonitrile, 2.5 ml acetic acid, and 125 μl triethylamine (v/v). The pH of the whole mixture was adjusted to 3.4. A flow rate of 0.5 ml/min was employed throughout with a 15 μl injection volume. Detection was done using a UV detector at 291 nm. The validated method was linear for concentrations ranging from 15-180 ng/ ml with a good separation and specificity for both PRN and its internal standard, oxprenolol (OXP), with excellent recoveries, precision, and accuracies. The limit of detection (LOD) and limit of quantification (LOQ) were 1 and 10 ng/ml, respectively. The stability studies demonstrated that PRN is stable in the autosampler vials and also up to 3.5 months. To the authors' knowledge, the recovery, that ranged between 97.9-102.7%, is the highest among all previously reported methods that used HPLC with UV detection. The developed and validated method for PRN analysis is excellen,t and applicable to a clinical study.
AB - Many previous published methods for the quantitative determination of propranolol (PRN) in human plasma have poor recoveries and were not validated according to the FDA guideline. The aim of this study is to develop a simple HPLC method for detecting PRN in human plasma and to validate it so that it can be applied to a clinical study. Chromatographic separation was achieved using a mixture of a mobile phase consisting of 160 ml water, 180 ml methanol, 70 ml acetonitrile, 2.5 ml acetic acid, and 125 μl triethylamine (v/v). The pH of the whole mixture was adjusted to 3.4. A flow rate of 0.5 ml/min was employed throughout with a 15 μl injection volume. Detection was done using a UV detector at 291 nm. The validated method was linear for concentrations ranging from 15-180 ng/ ml with a good separation and specificity for both PRN and its internal standard, oxprenolol (OXP), with excellent recoveries, precision, and accuracies. The limit of detection (LOD) and limit of quantification (LOQ) were 1 and 10 ng/ml, respectively. The stability studies demonstrated that PRN is stable in the autosampler vials and also up to 3.5 months. To the authors' knowledge, the recovery, that ranged between 97.9-102.7%, is the highest among all previously reported methods that used HPLC with UV detection. The developed and validated method for PRN analysis is excellen,t and applicable to a clinical study.
KW - HPLC
KW - Propranolol
KW - UV
UR - http://www.scopus.com/inward/record.url?scp=77149160335&partnerID=8YFLogxK
U2 - 10.3109/15376511003602112
DO - 10.3109/15376511003602112
M3 - Article
C2 - 20128736
AN - SCOPUS:77149160335
SN - 1537-6516
VL - 20
SP - 137
EP - 142
JO - Toxicology Mechanisms and Methods
JF - Toxicology Mechanisms and Methods
IS - 3
ER -