Validation of a LC method for the analysis of oxaliplatin in a pharmaceutical formulation using an experimental design.
A rapid and sensitive RP-HPLC method with UV detection for routine control of oxaliplatin in a pharmaceutical formulation (Eloxatin) was developed. Quantitation was accomplished with the internal standard method. The procedure was validated by linearity (correlation coefficient=0.999948), accuracy, robustness and intermediate precision. Experimental design was used during validation to calculate method robustness and intermediate precision. For robustness test three factors were considered: percentage v/v of acetonitrile, flow rate and temperature; an increase in the flow rate results in a decrease of the drug found concentration, while the percentage of organic modifier and temperature have no important effect on the response. For intermediate precision measure the considered variables were: analyst, equipment and days. The RSD value (2.27%, n=24) indicated a good precision of the analytical method.
Ficarra
R
R
Dipartimento di Scienze Farmaco-Biologiche, Università di Catanzaro Magna Graecia, Complesso Ninì Barbieri, 88021 Roccelletta di Borgia, Catanzaro, Italy. pficarra@pharma.unime.it
Calabrò
M L
ML
Cutroneo
P
P
Tommasini
S
S
Melardi
S
S
Semreen
M
M
Furlanetto
S
S
Ficarra
P
P
Altavilla
G
G
D000970:Antineoplastic Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D016014:Linear Models; D009944:Organoplatinum Compounds / Q000032:analysis*; D000077150:Oxaliplatin; D004364:Pharmaceutical Preparations / Q000737:chemistry; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D004364:Pharmaceutical Preparations; D000077150:Oxaliplatin