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Sci. Pharm. 2013, 81(1), 167-182; doi:10.3797/scipharm.1210-12

Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of Sulfadiazine Sodium and Trimethoprim in Injectable Solution Formulation

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Accepted: 22 November 2012 / Published: 22 November 2012
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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.
Keywords: Sulfadiazine sodium; Trimethoprim; Bactizine® forte injectable solution; Validation; Stability indicating method Sulfadiazine sodium; Trimethoprim; Bactizine® forte injectable solution; Validation; Stability indicating method
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

GHANEM, M.M.; ABU-LAFI, S.A. Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of Sulfadiazine Sodium and Trimethoprim in Injectable Solution Formulation. Sci. Pharm. 2013, 81, 167-182.

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