دورية أكاديمية
Evaluation of the pharmaceutical quality of docetaxel injection using new stability indicating chromatographic methods for assay and impurities.
| العنوان: | Evaluation of the pharmaceutical quality of docetaxel injection using new stability indicating chromatographic methods for assay and impurities. |
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| المؤلفون: | Malleswara Reddy A; Analytical Research and Development, Integrated Product Development, Dr. Reddyâs Laboratories Ltd., Bachupally, Hyderabad-500 072, India. malleswarareddya@drreddys.com, Banda N, Govind Dagdu S, Venugopala Rao D, Kocherlakota CS, Krishnamurthy V |
| المصدر: | Scientia pharmaceutica [Sci Pharm] 2010 Apr-Jun; Vol. 78 (2), pp. 215-31. Date of Electronic Publication: 2010 Mar 05. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: MDPI Country of Publication: Switzerland NLM ID: 0026251 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2218-0532 (Electronic) Linking ISSN: 00368709 NLM ISO Abbreviation: Sci Pharm Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Publication: 2016- : Basel, Switzerland : MDPI Original Publication: Wien : Österreichische Apotheker-Verlagsgesellschaft |
| مستخلص: | 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. |
| References: | J Pharm Biomed Anal. 2006 May 3;41(2):676-81. (PMID: 16473490) J Pharm Biomed Anal. 2007 Mar 12;43(4):1228-35. (PMID: 17126518) J Pharm Biomed Anal. 2006 Feb 24;40(3):614-22. (PMID: 16330175) J Pharm Biomed Anal. 1998 Sep;17(8):1243-7. (PMID: 9800643) J Chromatogr B Biomed Sci Appl. 2001 Aug 15;759(2):299-306. (PMID: 11499483) J Chromatogr B Biomed Sci Appl. 1997 Jun 6;693(2):437-41. (PMID: 9210450) Curr Med Res Opin. 2008 Jul;24(7):2019-33. (PMID: 18544188) Dev Biol Stand. 1998;93:211-9. (PMID: 9737398) |
| فهرسة مساهمة: | Keywords: Docetere; Excipients; HPLC; Impurities; Quality; Stability indicating Note: Original DateCompleted: 20111110 |
| تواريخ الأحداث: | Date Created: 20101224 Date Completed: 20120409 Latest Revision: 20240324 |
| رمز التحديث: | 20240324 |
| مُعرف محوري في PubMed: | PMC3002803 |
| DOI: | 10.3797/scipharm.0912-14 |
| PMID: | 21179344 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2218-0532 |
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| DOI: | 10.3797/scipharm.0912-14 |