Abstract
A direct, precise, and stability-indicating HPLC method that is based on reversed-phase liquid chromatography (RP-HPLC) coupled with a photodiode array detector (PDA) was developed, optimized, and validated for the simultaneous determination of sulfadiazine sodium (SDZS) and Trimethoprim (TMP) in Bactizine® forte injectable solution. The separation was achieved using a C18 column (250 mm×4.6 mm i.d., 5 μm particle size) at room temperature, and an isocratic mobile phase that consisted of a trinary solvent mixture of water–acetonitrile–triethylamine (838:160:2, v/v) at pH 5.5 ± 0.05. The mobile phase was delivered at 1.4 ml/min and the analytes were monitored at 254 nm. The effects of the operational chromatographic conditions on the peak’s USP tailing factor, column efficiency, and resolution were systematically optimized. Forced degradation experiments were carried out by exposing SDZS, TMP standards, and their formulation to thermal, photolytic, oxidative, and acid-base hydrolytic stress conditions. The method was successfully validated in accordance to International Conference on Harmonization (ICH) and United States Pharmacopoeia (USP34/NF29) guidelines and found to be suitable for the quantitative determination and stability of SDZS and TMP in Bactizine® forte injectable solution.
Highlights
Bactizine® forte injectable solution is a synergistic combination of two antibacterial substances, sulfadiazine sodium (SDZS) and trimethoprim (TMP), at a concentration of 200mg of SDZS and 40mg of TMP per each milliliter of the injectable solution
Method development and optimization The aim of the developed RP-HPLC method was to resolve SDZS from TMP and from the placebo which consisted of water, benzyl alcohol, and glycerol to comply with the requirements of the system suitability test
The validated HPLC method developed for the quantitative quality control determination of SDZS and TMP in Bactizine® forte injectable solution was evaluated over linearity, range, precision, system suitability, accuracy, specificity, ruggedness, and robustness
Summary
Bactizine® forte injectable solution is a synergistic combination of two antibacterial substances, sulfadiazine sodium (SDZS) and trimethoprim (TMP), at a concentration of 200mg of SDZS and 40mg of TMP per each milliliter of the injectable solution It is recommended for the treatment of alimentary, respiratory, urinary tract, skin, and soft tissue infections caused by susceptible organisms, including E.coli, Enterobacter, Klebsiella, Streptococcus, Staphylococcus, Pasteurella, Clostridia, Salmonella, Shigella, Brucella spp., Actinomyces, Corynebacterium spp., Bordetella spp., Nisseria spp., Vibrio spp., and Proteus organisms. It is especially useful for the long-term and short-term treatment of chronic bacterial urinary tract infections.
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