Abstract
ABSTRACT A simple, economic, and time-efficient related substance, GC method has been developed for the analysis of 1,4-Cyclohexanedione mono- ethylene ketal(will be specified as ketal) in the presence of a potential impurity 1,4-cyclohexa- nedione bis (ethylene ketal) [will be specified as diketal]. Successful chromatographic separa- tion of the ketal from the impurity was achieved on a DBWAX ETR, 30 m x 0.32 mm x 1.0μ FT column with nitrogen as carrier gas and FID detector. The method was validated for linearity, accuracy, precision, and specificity and can be used for quality control during manufacture of ketal. A validated GC method is reported for the ketal for the first time.
Highlights
Ketal chemically 1,4-Cyclohexanedione mono-ethylene ketal is a potential intermediate in organic synthesis [1,2,3]
The injection volume was 2.0 μL, the carrier flow was 7.5 psi constant pressure, the detector temperature was 260°C, the injector temperature was 250°C and oven temperature was began at 45°C, held for 4 minutes and was raised to 250°C at 60°C min-1 and held for 28 minutes, and detection was with flame ionisation detector (FID)
The injection volume was 1.0 μL, the carrier flow was 7.5 psi constant pressure, the detector temperature was 260°C, the injector temperature was 250°C and oven temperature was began at 45°C, held for 4 minutes and was raised to 250°C at 60°C min-1 and held for 28 minutes, and detection was with flame ionisation detector (FID)
Summary
Ketal chemically 1,4-Cyclohexanedione mono-ethylene ketal is a potential intermediate in organic synthesis [1,2,3]. This paper describes a simple GC method, which separates ketal from diketal. In accordance with regulatory guidelines, pharmaceutical studies using a sample of the isolated impurities can be used for the safety assessment. It is, essential to isolate and characterize unidentified impurities present in the drugs. This paper reports, for the first time, a rapid, efficient, simple, and validated GC method for separation of potential impurity. To the best of our knowledge no validated method for the separation of ketal from its potential impurity was available by any of the instrumental technique and we have taken this study on the validation of ketal by GC method
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