Article

A Validated HPLC Assay Method for the Determination of Sodium Alginate in Pharmaceutical Formulations.

1Methodology Department, Research and Development Sector, Sigma Pharmaceutical Industries, 1st Quarter, Industrial Zone, Quesna, El Monofeya, Egypt.
Journal of chromatographic science (impact factor: 0.88). 07/2012; DOI:10.1093/chromsci/bms129
Source: PubMed

ABSTRACT A high-performance liquid chromatography-diode array detector method was developed and validated for the quantification of sodium alginate in antacid oral suspension using a phenyl stationary phase and buffer solution at pH 7.0 as a mobile phase. The method was validated for specificity, linearity, range, accuracy, precision and robustness. The method was specific for the determination of sodium alginate in the bulk drug, pharmaceutical dosage form and under stress degradation. The method was linear over the range of 600 to 1,400 µg/mL with r(2) = 0.9999, and accuracy and precision were acceptable with relative standard deviation < 2.0%. The described method is simple, specific, precise, accurate, robust and stability-indicating, and can be successfully applied for the routine analysis of sodium alginate in bulk drug and pharmaceutical dosage form.

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Keywords

antacid oral suspension
 
bulk drug
 
described method
 
high-performance liquid chromatography-diode array detector method
 
linearity
 
mobile phase
 
pharmaceutical dosage form
 
phenyl stationary phase
 
precise
 
quantification
 
relative standard deviation
 
sodium alginate
 
specificity
 
stress degradation
 
validated