تطوير طريقة ذات مصدوقية لتعيين الايتانول في الأشكال الصيدلانية الصلبة بواسطة الكروماتوغرافيا الغازية مع استخدام الحيز الفوقي و مكشاف تأين اللهب

الملخص EN

This paper explains how to make validation of a HS-GC-FID method (based on the Pharmacopeia’s method) for the determination of ethanol residue in tablets.

A description of the procedure and simple calculation of validation parameters was presented.

Specificity of the method was determined.

Linearity was observed in the range from 2500 ppm to 6000 ppm of ethanol, Correlation Factor was 0.

994.

The relative standard deviation for repeatability and intermediate precision was 12.13 % and 6.6 % respectively.

The limit of detection was calculated to be 0.887 ppm of ethanol per sample.

The total run is 8 minutes.