Quantitative determination of the β-methyl carbapenem doripenem in powder for injection by a stability-indicating capillary zone electrophoresis method.
A capillary zone electrophoresis method for quantitative determination of doripenem in synthetic matrix was developed. The stability-indicating capability was performed applying stress testing protocols. The selected analytical conditions include 100 mM sodium borate buffer (pH 8.0) as run electrolyte, voltage of +15 kV, hydrodynamic injection of 5s (50 mBar), detection at 298 nm and temperature of analysis of 25 degrees C. The electrophoretic separation was carried out in a fused silica capillary (effective length 40 cm, 50 μm i.d.), using procainamide hydrochloride as internal standard. The proposed method showed quickness and reproducibility, with an analytical run in a total time of 5 min. The percentage of drug amount estimated was 101.33% (RSD = 0.80), with satisfactory intra-day and inter-day precision. In the recovery test, the method was found to be reliable and accurate in the drug quantitation (mean recovery = 101.86%). The robustness was performed applying the Plackett-Burman experimental design which confirmed the assay reliability. Based on results from forced degradation study, the stability-indicating capability was established, being observed a major degradation in alkaline, photolytic and thermal conditions. In comparison to HPLC method previously developed, the proposed capillary electrophoresis assay is statistically equivalent.
P K
PK
Paliosa
C V
CV
Garcia
E E S
EE
Schapoval
A S L
AS
Mendez
M
M
Steppe
D000900:Anti-Bacterial Agents / Q000032:analysis*; D015780:Carbapenems / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D000077726:Doripenem; D004355:Drug Stability; D019075:Electrophoresis, Capillary; D007267:Injections; D057230:Limit of Detection; D011208:Powders; D012015:Reference Standards; D015203:Reproducibility of Results
D000900:Anti-Bacterial Agents; D015780:Carbapenems; D011208:Powders; D000077726:Doripenem