Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations
Joint Authors
Shakya, Ashok K.
Singh, Rahul
Naik, Rajashri
Shalan, Naeem
Source
International Journal of Analytical Chemistry
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-12, 12 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-03-08
Country of Publication
Egypt
No. of Pages
12
Main Subjects
Abstract EN
A simple, sensitive, inexpensive, and rapid stability indicating high performance liquid chromatographic method has been developed for determination of gemcitabine in injectable dosage forms using theophylline as internal standard.
Chromatographic separation was achieved on a Phenomenex Luna C-18 column (250 mm × 4.6 mm; 5μ) with a mobile phase consisting of 90% water and 10% acetonitrile (pH 7.00±0.05).
The signals of gemcitabine and theophylline were recorded at 275 nm.
Calibration curves were linear in the concentration range of 0.5–50 μg/mL.
The correlation coefficient was 0.999 or higher.
The limit of detection and limit of quantitation were 0.1498 and 0.4541 μg/mL, respectively.
The inter- and intraday precision were less than 2%.
Accuracy of the method ranged from 100.2% to 100.4%.
Stability studies indicate that the drug was stable to sunlight and UV light.
The drug gives 6 different hydrolytic products under alkaline stress and 3 in acidic condition.
Aqueous and oxidative stress conditions also degrade the drug.
Degradation was higher in the alkaline condition compared to other stress conditions.
The robustness of the methods was evaluated using design of experiments.
Validation reveals that the proposed method is specific, accurate, precise, reliable, robust, reproducible, and suitable for the quantitative analysis.
American Psychological Association (APA)
Singh, Rahul& Shakya, Ashok K.& Naik, Rajashri& Shalan, Naeem. 2015. Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations. International Journal of Analytical Chemistry،Vol. 2015, no. 2015, pp.1-12.
https://search.emarefa.net/detail/BIM-1064450
Modern Language Association (MLA)
Singh, Rahul…[et al.]. Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations. International Journal of Analytical Chemistry No. 2015 (2015), pp.1-12.
https://search.emarefa.net/detail/BIM-1064450
American Medical Association (AMA)
Singh, Rahul& Shakya, Ashok K.& Naik, Rajashri& Shalan, Naeem. Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations. International Journal of Analytical Chemistry. 2015. Vol. 2015, no. 2015, pp.1-12.
https://search.emarefa.net/detail/BIM-1064450
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1064450