Development and Validation of the Spectrophotometric Method for the Quantitative Determination of Azlocillin in Pure Substance and Medical Preparation

Abstract

Objective: The kinetic of conjugated reactions of S-oxidation and perhydrolysis of Azlocillin (Azl) with
potassium caroate in alkaline medium is studied by the increase of forming product light absorbance at 275 nm.
Materials and Methods: Securopen® - powder Azl sodium in flacons for the preparation of solution for injections
(Azl 1.0 g and 5.0 g) was used for analysis. Peroxymonosulfate acid as triple potassium salt 2КÐSO5∙КÐSO4∙K2SO4
(Oxone®) of “extra pure†qualification was used as oxidant. A scheme of peroxyacid oxidation and perhydrolysis
conjugated reactions of Azl by means of potassium caroate is proposed. A new spectrophotometric method for
the quantitative determination of sodium Azl in Securopen® preparation using potassium caroate (KHSO5) as an
analytical reagent was proposed. Results: At pH 2–3 for 1 mole of penicillin, 1 mole of KHSO5 is consumed,
and the quantitative interaction is achieved within a time of more than 1 min (observation time). The results were
obtained by the recommended procedure for seven replicate titrations of mixtures containing the three species
at various concentrations. Relative standard deviation (RSD) = (0.96–2.02) %, δ = (+0.49 … – 0.33)%. It can
be seen that Azl can be determined successively with good accuracy and reproducibility. Conclusions: The new
procedure was developed and the ability of quantitative determination of penicillin in pharmaceutical preparation
Securopen® by spectrophotometric method using potassium caroate (KHSO5) as analytical reagent was shown.