A stability-indicating HPLC assay method for docetaxel

被引：55

作者：

Rao, BM ^{[1
]}

Chakraborty, A

Srinivasu, MK

Devi, ML

Kumar, PR

Chandrasekhar, KB

Srinivasan, AK

Prasad, AS

Ramanatham, J

机构：

[1] Dr Reddys Labs, Custom Pharmaceut Serv, Analyt Res, Hyderabad 500049, Andhra Pradesh, India

[2] Dr Reddys Labs, Custom Pharmaceut Serv, Plant Management, Hyderabad 500049, Andhra Pradesh, India

[3] Jawaharlal Nehru Univ, Coll Engn, Dept Chem, Anantapur 515002, Andhra Pradesh, India

[4] Dr Reddys Labs, Custom Pharmaceut Serv, Proc Res, Hyderabad 500049, Andhra Pradesh, India

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2006年 / 41卷 / 02期

关键词：

RP-LC; forced degradation; validation; solution stability; diode array detector (DAD);

D O I：

10.1016/j.jpba.2006.01.011

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for docetaxel in the presence of degradation products generated from forced decomposition studies. A gradient HPLC method was developed to separate the drug from the degradation products, using a Hichrom RPB HPLC column. Mixture of water and acetonitrile was used as mobile phase. The flow rate was 1.0 ml/min and the detection was done at 230 nm. Using the above method one can carry out the quantitative estimation of impurity namely DCT-1 and docetaxel. The developed gradient LC method was subsequently validated. (c) 2006 Elsevier B.V. All rights reserved.

引用

页码：676 / 681

页数：6

共 4 条

[1]

BAKSHI M, 2001, J PHARM BIOMED ANAL, V26, P1011, DOI DOI 10.1016/S0731-7085(01)00475-7

[2] Simple and sensitive high-performance liquid chromatography method for the determination of docetaxel in human plasma or urine [J].

Garg, MB ;

Ackland, SP .

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2000, 748 (02) :383-388

[3] Rapid analysis of docetaxel in human plasma by tandem mass spectrometry with on-line sample extraction [J].

Grozav, AG ;

Hutson, TE ;

Zhou, X ;

Bukowski, RM ;

Ganapathi, R ;

Xu, Y .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2004, 36 (01) :125-131

[4]

*ICH, ICH HARM TRIP GUID

← 1 →