Development of an ion-pairing reversed-phase liquid chromatography method using a double detection analysis (UV and evaporative light scattering detection) to monitor the stability of Alimta(®)-pemetrexed preparations: identification and quantification of

Abstract:

:A new method based on high-performance liquid chromatography coupled to ultraviolet and evaporative light scattering detection (HPLC-UV-ELSD) was developed for the determination of L-glutamic acid, a potential degradation product of pemetrexed, and for the quantification of pemetrexed itself. This is an ion-pairing, reversed-phase method. The column was a Synergi MAX-RP C12 4 μm (150 mm x 4.6 mm). The mobile phase was 1 mM tridecafluoroheptanoic acid in aqueous solution and acetonitrile under gradient elution mode. L-Glutamic acid was detected by ELSD, and pemetrexed by UV at 254 nm. Good resolution was achieved between pemetrexed and L-glutamic acid. The HPLC method was validated according to SFSTP and ICH guidelines, and applied the accuracy profile procedure with a five-level validation experimental design. For pemetrexed, the decision criteria selected consisted of the acceptability limits (±3%) and the proportion of results within the calculated tolerance intervals (95%). In conclusion, the proposed analytical procedures were validated over the selected validation domains for L-glutamic acid (0.005-0.025 mg/mL) and pemetrexed (0.4-0.6 mg/mL) and shown to provide a very effective method.

journal_name

J Pharm Biomed Anal

authors

Respaud R,Tournamille JF,Croix C,Laborie H,Elfakir C,Viaud-Massuard MC

doi

10.1016/j.jpba.2010.08.031

subject

Has Abstract

pub_date

2011-01-25 00:00:00

pages

411-6

issue

2

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(10)00511-X

journal_volume

54

pub_type

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