Testing of oxytetracyclin tablets

Testing of oxytetracyclin tablets

Test samples: Capsules, marked Oxytetra LETAP , color red and yellow, stated to be oxytetracyclin

Standard: Oxytetral 250 mg (Actavis)


Assay of test sample and standard:
One tablet of standard substance was crushed and extracted with 25 mL of methanol. Of this, 1 mL was mixed with 19 mL methanol to give assay solution of standard. Three capsules of test substance were opened separately and treated in the same way as the standard to give assay solutions 1-3 of test substance. Ca 2 microliter of each of the assay solutions were applied to a reverse phase TLC plate (Merck, RP18 F254s). The plate was developed with methanol - acetonitrile - ammonium oxalate buffer (63 g oxalic acid/L, pH 2) (20-20-60, v/v/v) and spots were visualized with short-wave UV irradiation (254 nm) (Ph.Eur, 2007).

Results:
In the standard sample and in all three test samples, one spot was observed in short wave UV light (254 nm) at the same Rf value. No other spots were observed.

Conclusion:
The samples of Oxytetra LETAP contains oxytetracycline according to the European Pharmacopoeia. No other substances were found.


Tested by:

Karl Egil Malterud Xuan Nguyen
Professor Student
Oslo, April 24, 2008

Reference:

European Pharmacopoeia, ver. 5 (2007) Oxytetracyclin hydrochloride. Council of Europe, Strasbourg, pp 4286-7.