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Table 1 Summary of optimized liquid chromatographic and mass spectrometric method conditions

From: An efficient HILIC-MS/MS method for the trace level determination of three potential genotoxic impurities in aripiprazole active drug substance

Parameter

Condition

Liquid chromatography conditions

 Mobile phase A

Acetonitrile:ammonium formate buffer (pH 6) (95:5).

 Mobile phase B

Acetonitrile:ammonium formate buffer (pH 6) (50:50).

 Auto-sampler temperature

25 °C

 Column temperature

35 °C

 Flow rate

0.8 mL/min

 Injection volume

10 μL

 Gradient program (time/mobile phase B)

0/5, 3/10, 6/40, 8/70, 10/70

 Run time

10 min

Mass spectrometry conditions

 Source

ESI

 Ionization mode

Positive

 Capillary voltage

3.0 kV

 Detection mode

MRM

 MRM transitions (m/z) selected

PGI-1

PGI-2

PGI-3

 For qualification

163.1 > 126.3

143.1 > 63.1

80.5 > 63.1

 For quantification

163.1 > 90.1

143.1 > 107.1

80.5 > 45.1

 Sample cone

15 V

 Probe temperature

150 °C

 Heating block temperature

280 °C

 Desolvation (DL) temperature

300 °C

 Nebulization and drying gas

Nitrogen

 Nebulization gas flow

1.0 mL/min

 Drying gas flow

900 L/h

 CID gas

Argon