Development and validation of a capillary electrophoresis method with capacitively coupled contactless conductivity detection (CE‐C⁴D) for the analysis of amikacin and its related substances

Abstract

Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin A that lacks a strong UV absorbing chromophore or fluorophore. Due to the physicochemical properties of amikacin and its related substances, CE in combination with capacitively coupled contactless conductivity detection (CE‐C4D) was chosen. The optimized separation method uses a BGE composed of 20 mM MES adjusted to pH 6.6 by l‐histidine and 0.3 mM CTAB that was added as flow modifier in a concentration below the CMC. Ammonium acetate 20 mg.L−1 was used as internal standard. 30 kV was applied in reverse polarity on a fused silica capillary (73/48 cm; 75 μm id). The optimized separation was obtained in less than 6 min with good linearity (R2 = 0.9996) for amikacin base. It shows a good precision expressed as RSD on relative peak areas equal to 0.1 and 0.7% for intraday and interday, respectively. The LOD and LOQ are 0.5 mg.L−1 and 1.7 mg.L−1, respectively.

Contactless conductivity detection for analytical techniques—Developments from 2012 to 2014

“…A range of adulterants, usually synthetic compounds added to natural pharmaceutical formulations, was evidenced in several herbal formulations by recent CE‐C 4 D studies . Various painkillers , antibiotics , antihypertensives , muscle relaxants , and enzyme inhibitors were determined in pharmaceutical formulations in order to prove their composition and content of active ingredients. CE‐C 4 D also enables determination of the active ingredient and its counterion, which may often reveal counterfeit medicines, which is a serious problem for medicine markets in poor countries.…”

Challenges in the determination of aminoglycoside antibiotics, a review

“…LODs were ranging from 1.2 µM for amikacin to 6.7 µM for lincomycin [76]. CE coupled to contactless conductivity detection was used for the determination of amikacin [77] and tobramycin [78] with their related impurities.…”

Determination of impurities and counterions of pharmaceuticals by capillary electromigration methods

“…CE methods have been applied for the impurity studies of the drugs with various types of pharmacological activities such as chemotherapeutic agents , cardiovascular drugs , antithrombotics , antihistaminic drugs , corticosteroids , analgesics , anaesthetics , antidepressants , central nervous system drugs , antimuscarinics , antibiotics , antiviral drugs , and antimalarial drugs . CE methods are increasingly being viewed as an alternative and/or complement to HPLC for analysis of various types of impurities observed during the drug production or storage.…”