Research Of The Defferential Refraction-HPLC Method About Assay Testing Of Sisomicin Sulate Ingredient And Product

Sisomicin sulfate is a new generations of Aminoglycoside antibiotics, which is widely applied in clinical practice. It not only makes up deficiency of traditional Aminoglycoside antibiotics, but also has broad Antibacterial spectrum compared to traditional ones. It puts forward higher requirements of its analytical method, especially for the active component determination, because of the wide application of sisomicin sulfate formulations.The current analytical method is microbiological test in our company, and there are some deficiencies such as data repeatability being not good, high requirement for environment. The Differential refraction-HPLC detector method is established on current analytical method and relevant research literatures. Chromatographic column is C₁₈ column (4.6×250mm, 5μm), mobile phase is a mixture of 0.02mol/l trifluoroacetic acid: methanol (95:5), flow rate is 1.0ml/min and column temperature is 35℃. Moreover, methodological validation of the method is performed: the recovery is 99.3% for Sisomicin sulfate API, 99.4% for Sisomicin sulfate injection. The linearity equation is Y=261623X+6183, r=0.9995 for concentrations between 0.1 mg/ml and 2.5mg/ml.Through methodological validation and compared to current method, the established method is more convenient, accurate and specific, which is able to satisfy the requirements of quality control and production.