Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations
Joint Authors
Bayat, Sima
Sadeghi, Fahimeh
Afshar, Minoo
Navidpour, Latifeh
Source
Journal of Analytical Methods in Chemistry
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-09-17
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
A green, simple, and stability-indicating RP-HPLC method was developed for the determination of diltiazem in topical preparations.
The separation was based on a C18 analytical column using a mobile phase consisted of ethanol: phosphoric acid solution (pH = 2.5) (35 : 65, v/v).
Column temperature was set at 50°C and quantitation was achieved with UV detection at 240 nm.
In forced degradation studies, the drug was subjected to oxidation, hydrolysis, photolysis, and heat.
The method was validated for specificity, selectivity, linearity, precision, accuracy, and robustness.
The applied procedure was found to be linear in diltiazem concentration range of 0.5–50 μg/mL (r2=0.9996).
Precision was evaluated by replicate analysis in which % relative standard deviation (RSD) values for areas were found below 2.0.
The recoveries obtained (99.25%–101.66%) ensured the accuracy of the developed method.
The degradation products as well as the pharmaceutical excipients were well resolved from the pure drug.
The expanded uncertainty (5.63%) of the method was also estimated from method validation data.
Accordingly, the proposed validated and sustainable procedure was proved to be suitable for routine analyzing and stability studies of diltiazem in pharmaceutical preparations.
American Psychological Association (APA)
Sadeghi, Fahimeh& Navidpour, Latifeh& Bayat, Sima& Afshar, Minoo. 2013. Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations. Journal of Analytical Methods in Chemistry،Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-465248
Modern Language Association (MLA)
Sadeghi, Fahimeh…[et al.]. Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations. Journal of Analytical Methods in Chemistry No. 2013 (2013), pp.1-10.
https://search.emarefa.net/detail/BIM-465248
American Medical Association (AMA)
Sadeghi, Fahimeh& Navidpour, Latifeh& Bayat, Sima& Afshar, Minoo. Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations. Journal of Analytical Methods in Chemistry. 2013. Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-465248
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-465248