Development of a new HPLC method for the simultaneous determination of ticarcillin and clavulanic acid in pharmaceutical formulations.
A new HPLC method has been developed and validated for the simultaneous determination of ticarcillin (TIC) and clavulanic acid (CA) in pharmaceutical formulations. The HPLC separation was achieved on a beta-cyclodextrin column (Cyclobond I, 250 x 4.6 mm, 5 microm) with methanol-16 mM pH 6.0 ammonium acetate buffer (50 + 50, v/v) mobile phase at a flow rate of 0.8 mL/min. Detection was at 220 nm. Validation of the method was performed by evaluating specificity, robustness, accuracy, and precision. The calibration curves were linear in the range of 1-100 microg/mL for CA and 2-200 microg/mL for TIC. The LOQs based on the standard regression lines were 0.42 and 1.42 microg/mL for CA and TIC, respectively, and the LOD were 0.14 and 0.47 microg/mL, respectively. Total recoveries of synthetic mixtures (CA:TIC = 1:10, 1:15, and 1:30) were 99.25-100.99% for CA and 99.54-100.82% for TIC. Compared with the U.S. Pharmacopeia method, the proposed method has the advantage of a relatively low flow rate and short analysis time. The proposed method was successfully applied for the simultaneous determination of these two drugs in sterilized H20 and 5% dextrose injection solutions.
Tsou
Tai-Li
TL
Kaohsiung Medical University, College of Pharmacy, Faculty of Pharmacy, Kaohsiung, Taiwan.
Lee
Chiu-Wey
CW
Wang
Hsian-Jenn
HJ
Cheng
Ya-Chung
YC
Liu
Yu-Tien
YT
Chen
Su-Hwei
SH
D000900:Anti-Bacterial Agents / Q000032:analysis*; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D019818:Clavulanic Acid / Q000032:analysis*; D004338:Drug Combinations; D004355:Drug Stability; D004791:Enzyme Inhibitors / Q000032:analysis*; D006358:Hot Temperature; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D012015:Reference Standards; D015203:Reproducibility of Results; D013982:Ticarcillin / Q000032:analysis*; D014466:Ultraviolet Rays
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D004791:Enzyme Inhibitors; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D019818:Clavulanic Acid; D013982:Ticarcillin