Objective: To establish the method for content determination in quality evaluation of compound menthol nasal drops. Methods: Gas chromatography-mass spectrometry ( GC-MS ) was adopted to determine levels of menthol and camphor. GC-MS conditions included Agilent DB-5MS column ( 30 m × 250 μm × 0. 25 μm)

flow rate of 1 mL/ min

split ratio of 10 ∶ 1

injector temperature of 300 ℃

and temperature program (initial temperature of 90 ℃ for 5 min

followed by increase of 1 ℃ / min to 100 ℃ with 5-minute hold

and increase of 10 ℃ / min to 220 ℃ with 2-minute hold). The mass spectrometer used an electron impact (EI) source with temperature of 230 ℃

quadrupole temperature of 150 ℃

electron energy of 70 eV

and mass-to-charge ratio (m/ z) range of 30 to 800. Results: Menthol and camphor exhibited excellent linear relationships with peak areas within concentration ranges of 50. 20 to 803. 20 μg / mL (r = 0. 999

6) and 50. 10 to 801. 60 μg / mL (r = 0. 999

4)

respectively. The average recovery rates were 101. 5% and 101. 1% for menthol and camphor

respectively. The precision

stability and repeatability experiments yielded relative standard deviations (RSD) of less than 2%. Conclusion: A preliminary quantitative analysis method for menthol and camphor in compound menthol nasal drops has been established. The quality standards developed by using GC-MS are accurate and exhibit good reproducibility

which can be applied for the content determination and quality control of menthol and camphor in compound menthol nasal drops.