Separation of impurities with close structure is always challenging in pharmaceutical industry due to the strict requirements to acceptance criteria of chromatographic method and low limits for impurities quantification. This application shows the method for determination of related substances of cefazolin sodium by the Ph. Eur. Monograph. ARION® Polar C18 column allows to separate all impurities according to the method.
ABSTRACT
HPLC-UV determination of related substances of cefazolin sodium according to the Ph. Eur. Monograph on an ARION® Polar C18 3 µm column, 125 mm × 4.0 mm, part number ARI-5721-IJ40. Mobile phase A is a solution containing 14.54 g/L of disodium hydrogen phosphate dodecahydrate R and 3.53 g/L of potassium dihydrogen phosphate R; mobile phase B is acetonitrile R. Gradient elution (time interval / A% / B%): 0–2 / 98 / 2, 2–4 / 98 → 85 / 2 → 15, 4–10 / 85 → 60 / 15 → 40, 10–11.5 / 60 → 35 / 40 → 65, 11.5–12 / 35 / 65, 12–15 / 35 → 98 / 65 → 2, 15–21 / 98 / 2. Flow rate 1.2 mL/min, column temperature 45 °C, injection volume 5 µL, UV detection at 254 nm. Analytes as numbered in the note: 1. impurity J, 2. impurity E, 3. impurity H, 4. impurity C, 5. impurity G, 6. impurity D, 7. impurity…
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Cefazolin sodiumCAS number 27164-46-1
Impurity LCAS number not available
Impurity BCAS number not available
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