Abstract
A stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the determination of sodium bisulfate (SB), an antioxidant, in injectable dosage form. The chromatographic separation was achieved on a Zorbax CN (250 mm × 4.6 mm, 5 μm) column, with a mobile phase consisting of a buffer mixture of 0.03 M tetrabutylammonium hydrogen sulfate, 0.01 M potassium dihydrogen orthophosphate, and acetonitrile at a ratio of 70:30 (v/v) and a flow rate of 0.7 mL/min. The eluted compound was monitored at a wavelength of 215 nm using a UV detector. The method described herein separated sodium bisulfite from all other formulation components within a run time of 10 min. The method also generated linear results over an SB concentration range of 10 to 990 μg/mL, and the limit of quantification was found to be 10 μg/mL. The stability indicating capability of the method was established by performing forced degradation experiments. The RP-HPLC method that was developed was validated according to the International Conference on Harmonization (ICH) guidelines. This method was successfully applied in the quantitative determination of SB in a stability study of Amikacin sulfate injection. The procedure described herein is simple, selective, and reliable for routine quality control analysis as well as stability testing.
Highlights
Sodium bisulfite (SB) is an inorganic compound commonly used as an antioxidant in pharmaceutical formulations
The main criterion for developing an reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the determination of SB as an inorganic compound using a UV detector was to estimate the amount of SB in a single run, with emphasis on the method being accurate, reproducible, robust, stability indicating, linear, free of interference from other formulation excipients and convenient enough for routine use in quality control laboratories
A spiked solution of SB (660 μg/mL) and placebo peaks were subjected to separation by RP-HPLC
Summary
Sodium bisulfite (SB) is an inorganic compound commonly used as an antioxidant in pharmaceutical formulations. Antioxidants are excipients that are used to improve the stability of medicines by delaying the oxidation of active substances and other excipients and are classified into 3 groups [1]. The first group is known as true antioxidants, or antioxygen, which likely inhibit oxidation by reacting with free radicals and blocking chain reactions. The second group consists of reducing agents; these substances have lower redox potentials than the drug or adjuvant that they are intended to protect and are more readily oxidized. Reducing agents may operate by reacting with free radicals. The third group consists of antioxidant synergists that usually have little antioxidant effect themselves but are thought to enhance the action of antioxidants in the first group by reacting with heavy metal ions that catalyze oxidation.
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