Related substances control is a mandatory test in routine specification of active pharmaceutical ingredient. Сhromatographic method should meets the strict system suitability requirements that is often challenging due to close retention times of the studied compounds. ARION® column shows a robust and precise results in control of Zopiclone related substances in a long sequense of analysis.
ABSTRACT
HPLC-UV control of zopiclone related substances on an ARION® Plus C18 5 µm column, 250 mm × 4.6 mm, part number ARI-5720-LM46. Mobile phase: ACN and a solution containing 8.1 g/L of sodium laurilsulfate and 1.6 g/L of NaH2PO4, previously adjusted to pH 3.5 with a 10% H3PO4, in the ratio 38/62 (v/v), isocratic elution. Flow rate 1.5 mL/min, column temperature 30 °C, injection volume 20 µL, UV detection at 303 nm. Analytes as numbered in the note: 1. impurity B, 2. unknown impurity RT 7.25, 3. unknown impurity RT 18.87, 4. impurity A, 5. zopiclone, CAS number 43200-80-2; CAS numbers are given only for the active substance. The note shows four chromatograms on the ARION® column: reference solution (a) with only zopiclone (peak 5) at about 29 min; reference solution (b) with…
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Impurity BCAS number not available
Unknown impurity RT 7.25CAS number not available
Unknown impurity RT 18.87CAS number not available
Impurity ACAS number not available
ZopicloneCAS number 43200-80-2
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