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Densitometric and UV-Spectrophotometric Methods for Simultaneous Determination of Spiramycin adipate in Binary Mixture with Oxytetracycline-HCl or Tetracycline-HCl

Asmaa O. El Demerdash, Sawsan A. Abdel Razeq, Manal M. Fouad, Hoda F. El Sanabary

International Research Journal of Pure and Applied Chemistry · pp. 1–21 · Published 21 Sep 2018

10.9734/IRJPAC/2018/44345

Abstract

Five methods were developed for simultaneous determination of spiramycin adipate and oxytetracycline-HCl and/or tetracycline-HCl in their pharmaceutical formulations. The first one was a densitometric evaluation of thin-layer chromatograms using a mobile phase of methanol: Butanol: Chloroform: Ammonia 1% (5:1:1:1, by volume). The plates were visualized under UV lamp at 254 nm where spots appeared at Rf 0.76, 0.30 and 0.37 for spiramycin adipate, oxytetracycline-HCl and tetracycline-HCl, respectively. The chromatograms of the drugs were measured densitometrically at 240 nm for spiramycin adipate and at 350 nm for both oxytetracycline-HCl and tetracycline-HCl in the range of 0.1-0.8 µg mL-1 and 0.1-1.0 µg mL-1, respectively. Likewise, the simultaneous estimation of the cited drugs was performed by four spectrophotometric methods. Method A was a mean centering (MC) which provided spiramycin adipate determination at 232 nm together with oxytetracycline-HCl or tetracycline-HCl, both at 282, 286, 321, 324, 345 and 364 nm. Method B was a third derivative (3D) through which spiramycin adipate could be estimated at 256 nm while the wavelength 281 nm was selected for oxytetracycline-HCl or tetracycline-HCl determination. Method C was a derivative ratio (1DR) that was established to determine spiramycin adipate only in the presence of oxytetracycline-HCl or tetracycline-HCl at 225.6 and 240 nm. Method D was an induced dual wavelength (IDW) which allowed the determination of oxytetracycline-HCl in presence of spiramycin adipate and up to 50% of its impurity tetracycline. The calibration curves were linear over the concentration range of 5-70 µg mL-1 for spiramycin adipate and 5-60 µg mL-1 for both oxytetracycline-HCl and tetracycline-HCl. The obtained results were statistically analyzed and found to be in accordance with those given by reported methods. The validity of the methods was evaluated according to ICH guidelines.

Spiramycin oxytetracycline densitometry mean centering derivative dual wavelength

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