Rapid and Simple Methods for Determination of Medazepam in Pharmaceutical Preparations using GC-FID and GC-MS

Abstract

This paper describes two rapid, sensitive, and specific methods for the determination of medazepam with internal standard (diazepam) in pharmaceutical preparations by gas chromatography (GC) with flame ionization (FID) and mass spectrometric (MS) detection. The linearity was established over the concentration range of 0.25–5 µg/mL for GC-FID and 50–1000 ng/mL for GC-MS method. The intra- and inter-day relative standard deviation was less than 2.94 and 4.95%, respectively. Developed GC-FID and GC-MS methods in this study are accurate, sensitive, and precise and can be directly and easily applied to Tranko buskas as pharmaceutical preparation.

Keywords:

• GC-FID
• GC-MS
• medazepam
• validation

Notes

^a Standard deviation of six replicate determinations.

^b Relative standard deviation.

n: number of determination, S.D.: Standard deviation, R.S.D.: Relative standard deviation, t _c: calculated t-value, t _t: tabulated t-value, Ho hypothesis: no statistically significant difference exists between two methods, t _t > t _c; Ho hypothesis is accepted (P > 0.05).