ABSTRACT
A simple and rapid method for determination of 17 -estradiol in pharmaceutical preparation was developed and validated using gas
chromatography with flame ionization detection (GC-FID). The solutions of standard and the sample were prepared in methanol. GC
separation was performed in about 7.7 min using a 30 m x 0.32 mm I.D. (film thickness 0.25 µm) HP-5 capilary column. Nitrogen was
used as carrier gas at a flow-rate of 2 ml min-1
. After injection of the sample at inlet temperature 250 C, the temperature of the GC oven
was as follows: initial temperature was 150 C, held for 1.5 min, increased to 260 C at a rate of 50 C min-1
held for 5 min, and finally to
270 C at a rate of 10 C min-1
and held for 3.3 min. Detector temperature is 300 C. 2 µl was injected in splitless mode. Calibration
curves were linear between the concentration range 0.25-50 g ml-1
. The method was validated for specificity, linearity, precision,
accuracy and limit of quantitation. Also, the method was applied to directly and easily to the analysis of the pharmaceutical preparation
(Estrofem tablet).
Keywords: 17 -estradiol, GC-FID, Pharmaceutical preparation
ABSTRACT
A simple and rapid method for determination of 17 -estradiol in pharmaceutical preparation was developed and validated using gas
chromatography with flame ionization detection (GC-FID). The solutions of standard and the sample were prepared in methanol. GC
separation was performed in about 7.7 min using a 30 m x 0.32 mm I.D. (film thickness 0.25 µm) HP-5 capilary column. Nitrogen was
used as carrier gas at a flow-rate of 2 ml min-1
. After injection of the sample at inlet temperature 250 C, the temperature of the GC oven
was as follows: initial temperature was 150 C, held for 1.5 min, increased to 260 C at a rate of 50 C min-1
held for 5 min, and finally to
270 C at a rate of 10 C min-1
and held for 3.3 min. Detector temperature is 300 C. 2 µl was injected in splitless mode. Calibration
curves were linear between the concentration range 0.25-50 g ml-1
. The method was validated for specificity, linearity, precision,
accuracy and limit of quantitation. Also, the method was applied to directly and easily to the analysis of the pharmaceutical preparation
(Estrofem tablet).
Keywords: 17 -estradiol, GC-FID, Pharmaceutical preparation
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