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Sci. Pharm. 2011, 79(4), 909-920; doi:10.3797/scipharm.1104-13

A Stability Indicating Method for the Determination of the Antioxidant Sodium Bisulfite in Pharmaceutical Formulation by RP-HPLC Technique

1
Analytical Research Lab, Cadila Pharmaceutical Ltd, Dholka-387 810, Gujarat, India
2
P.S. Science and H.D. Patel Arts College, S.V. Campus, Kadi-382 715, Gujarat, India
*
Author to whom correspondence should be addressed.
Received: 18 April 2011 / Accepted: 7 August 2011 / Published: 7 August 2011
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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.
Keywords: Inorganic compound; Chromatography; Antioxidant; Assay; Method validation; Amikacin sulfate injection Inorganic compound; Chromatography; Antioxidant; Assay; Method validation; Amikacin sulfate injection
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

TRIVEDI, H.K.; PATEL, M.C. A Stability Indicating Method for the Determination of the Antioxidant Sodium Bisulfite in Pharmaceutical Formulation by RP-HPLC Technique. Sci. Pharm. 2011, 79, 909-920.

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