A stability-indicating HPLC assay method for docetaxel.
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.
Analytical Research, Custom Pharmaceutical Services, Dr. Reddy's Laboratories, Hyderabad 500049, India. bmrao67@rediffmail.com
B Mallikarjuna
BM
Rao
Arpita
A
Chakraborty
M K
MK
Srinivasu
M Lalitha
ML
Devi
P Rajender
PR
Kumar
K B
KB
Chandrasekhar
A K
AK
Srinivasan
A S
AS
Prasad
J
J
Ramanatham
D000972:Antineoplastic Agents, Phytogenic / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000077143:Docetaxel; D004355:Drug Stability; D015203:Reproducibility of Results; D043823:Taxoids / Q000032:analysis* / Q000737:chemistry; D013678:Technology, Pharmaceutical
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel