Development and validation of a CD-MEKC system for the simultaneous determination of dihydrostreptomycin sulfate and two benzylpenicillin salts

Abstract

A CD-MEKC system using sodium dodecyl sulfate and sulfated-β-cyclodextrin to achieve the simultaneous separation of Penicillin G procaine, Penicillin G benzatine and dihydrostreptomycin sulfate in pharmaceutical and veterinary dosage forms was developed. Several parameters were evaluated, including buffer type and concentration, cyclodextrin type and concentration, and organic solvent and instrumental parameters. The optimized system consisted of 50 mM SDS, 1% sulfated-ß-cyclodextrin, and 10 mM pH 9.0 borate buffer. Capillary temperature was kept at 35°C, and an electrophoretic system was operated under positive polarity at a constant voltage of 18 kV. Validation parameters such as specificity, linearity, LOD, and LOQ, precision, accuracy, and robustness were assayed. Therefore, the developed method was found to be appropriate for quality control of Penicillin G procaine, Penicillin G benzatine, and dihydrostreptomycin sulfate.