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Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets
Author
Source
Journal of Analytical Methods in Chemistry
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-08-22
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form.
Method development was performed on C 18, 100×4.6 mm ID, and 10 μm particle size column, and injection volume was 20 μL using a diode array detector (DAD) to monitor the detection at 280 nm.
The mobile phase consisted of buffer: acetonitrile at a ratio of 60 : 40 (v/v), and the flow rate was maintained at 1.0 mL/min.
The method was validated in terms of suitability, linearity, specificity, accuracy, precision, stability, and sensitivity.
Linearity was observed over the range of concentration 0.05–12.0 μg/mL, and the correlation coefficient was found excellent >0.999.
The method was specific with respect to rabeprazole sodium, and the peak purity was found 99.99%.
The method was precise and had relative standard deviations (RSD) less than 2%.
Accuracy was found in the range of 99.9 to 101.9%.
The method was robust in different variable conditions and reproducible.
This proposed fast, reliable, cost-effective method can be used as quality control tool for the estimation of rabeprazole sodium in routine dissolution test analysis.
American Psychological Association (APA)
Nawaz, Md. Saddam. 2013. Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets. Journal of Analytical Methods in Chemistry،Vol. 2013, no. 2013, pp.1-8.
https://search.emarefa.net/detail/BIM-512899
Modern Language Association (MLA)
Nawaz, Md. Saddam. Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets. Journal of Analytical Methods in Chemistry No. 2013 (2013), pp.1-8.
https://search.emarefa.net/detail/BIM-512899
American Medical Association (AMA)
Nawaz, Md. Saddam. Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets. Journal of Analytical Methods in Chemistry. 2013. Vol. 2013, no. 2013, pp.1-8.
https://search.emarefa.net/detail/BIM-512899
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-512899