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Table 1 HPLC analytical parameters for MT

From: Interchangeability and comparative effectiveness between generic and brand montelukast immediate release tablets after a single oral administration in healthy volunteers

Mobile phase

Buffer solution: dissolve 1.36 g potassium dihydrogen phosphate in 1 l and adjust PH to 4.0 with 20 % v/v phosphoric acid

Mix 1400 mL acetonitrile with 600 mL of buffer solution and filter through 0.45 µm membrane filter

Diluent

Mobile phase

HPLC

Waters system

Column

Inertsil ODS-2 (25 cm × 4.6 mm) 5 μm

Detector

355 nm

Flow rate

1.5 mL/min

Injection volume

50 µL

Column oven temperature

40 °C

Sample cooler temperature

NA

Standard solution preparation

Standard solution contains: 0.02 mg/mL of montelukast

Sample solution preparation

Standard solution contains: 0.02 mg/mL of montelukast

Run time

12 min

Filter

Nylon filter is suitable after discarding the first 3 mL

PTFE filter is suitable after discarding the first 3 mL