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Hewala I, El-Fatatry H, Emam E, et al. Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations. J AOAC Int. 2011;94(5):1447-60doi: 10.5740/jaoacint.10-129.
Hewala, I., El-Fatatry, H., Emam, E., & Mabrouk, M. (2011). Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations. Journal of AOAC International, 94(5), 1447-60. https://doi.org/10.5740/jaoacint.10-129
Hewala, Ismail, et al. "Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations." Journal of AOAC International vol. 94,5 (2011): 1447-60. doi: https://doi.org/10.5740/jaoacint.10-129
Hewala I, El-Fatatry H, Emam E, Mabrouk M. Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations. J AOAC Int. 2011 Sep-Oct;94(5):1447-60. doi: 10.5740/jaoacint.10-129. PMID: 22165009.
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J AOAC Int. 2011 Sep-Oct;94(5):1447-60. doi: 10.5740/jaoacint.10-129.

Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations.

Journal of AOAC International

Ismail Hewala, Hamed El-Fatatry, Ehab Emam, Mokhtar Mabrouk

Affiliations

  1. University of Alexandria, Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, Alexandria 21521, Egypt. [email protected]

PMID: 22165009 DOI: 10.5740/jaoacint.10-129

Abstract

A simple, rapid, and sensitive RP-HPLC method using photodiode array detection was developed and validated for the simultaneous determination of granisetron hydrochloride, 1-methyl-1H-indazole-3-carboxylic acid (the main degradation product of granisetron), sodium benzoate, methylparaben, propylparaben, and 4-hydroxybenzoic acid (the main degradation product of parabens) in granisetron oral drops and solutions. The separation of the compounds was achieved within 8 min on a SymmetryShield RP18 column (100 x 4.6 mm id, 3.5 microm particle size) using the mobile phase acetonitrile--0.05 M KH2PO4 buffered to pH 3 using H3PO4 (3+7, v/v). The photodiode array detector was used to test the purity of the peaks, and the chromatograms were extracted at 240 nm. The method was validated, and validation acceptance criteria were met in all cases. The robust method was successfully applied to the determination of granisetron and preservatives, as well as their degradation products in different batches of granisetron oral drops and solutions. The method proved to be sensitive for determination down to 0.04% (w/w) of granisetron degradation product relative to granisetron and 0.03% (w/w) 4-hydroxybenzoic acid relative to total parabens.

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