Next Article in Journal
3D-QSAR Design of New Escitalopram Derivatives for the Treatment of Major Depressive Disorders
Previous Article in Journal
A New Flavonoid C-Glycoside from Celtis australis L. and Celtis occidentalis L. Leaves and Potential Antioxidant and Cytotoxic Activities
Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Articles in this Issue were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence. Articles are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
Open AccessArticle

Evaluation of the Pharmaceutical Quality of Docetaxel Injection Using New Stability Indicating Chromatographic Methods for Assay and Impurities

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
Project Management, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2010, 78(2), 215-232; https://doi.org/10.3797/scipharm.0912-14
Received: 15 December 2009 / Accepted: 2 March 2010 / Published: 5 March 2010
New stability indicating chromatographic methods have been developed for estimation of Assay and Impurities of Docetaxel in Docetaxel injection for evaluation of pharmaceutical quality. With this method, the process related impurities and degradants are well separated from the peaks due to placebo. The relative retention times and relative response factors of the known impurities have been established. The LOQ of the known impurities and docetaxel are found to be less than 0.2 μg /ml and the recovery falls in the range of 90–110%. Peak purities demonstrated the stability indicating nature of the methods. The methods developed in the present study overcome the lacunae of the existing published methodologies in evaluation of the quality of Docetaxel injection. In essence, the present study provides an improved methodology for evaluation of the pharmaceutical quality of Docetaxel injection.
Keywords: HPLC; Quality; Stability indicating; Docetere; Impurities; Excipients HPLC; Quality; Stability indicating; Docetere; Impurities; Excipients
MDPI and ACS Style

MALLESWARA REDDY, A.; BANDA, N.; GOVIND DAGDU, S.; RAO, D.V.; KOCHERLAKOTA, C.S.; KRISHNAMURTHY, V. Evaluation of the Pharmaceutical Quality of Docetaxel Injection Using New Stability Indicating Chromatographic Methods for Assay and Impurities. Sci. Pharm. 2010, 78, 215-232.

Show more citation formats Show less citations formats

Article Access Map by Country/Region

1
Only visits after 24 November 2015 are recorded.
Back to TopTop