title: Evaluation of the pharmaceutical quality of docetaxel injection using new stability indicating chromatographic methods for assay and impurities.
abstract: 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 Îg /ml and the recovery falls in the range of 90â110%. 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.
authors.affiliation: Analytical Research and Development, Integrated Product Development, Dr. Reddyâs Laboratories Ltd., Bachupally, Hyderabad-500 072, India. malleswarareddya@drreddys.com
authors.forename: Annarapu
authors.initials: A
authors.lastname: Malleswara Reddy
authors.forename: Nagaraju
authors.initials: N
authors.lastname: Banda
authors.forename: Shinde
authors.initials: S
authors.lastname: Govind Dagdu
authors.forename: Dama
authors.initials: D
authors.lastname: Venugopala Rao
authors.forename: Chandra Sekhar
authors.initials: CS
authors.lastname: Kocherlakota
authors.forename: Vyas
authors.initials: V
authors.lastname: Krishnamurthy