title: 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.
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.
authors.affiliation: University of Alexandria, Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, Alexandria 21521, Egypt. hewalapda2007@hotmail.com
authors.forename: Ismail
authors.initials: I
authors.lastname: Hewala
authors.forename: Hamed
authors.initials: H
authors.lastname: El-Fatatry
authors.forename: Ehab
authors.initials: E
authors.lastname: Emam
authors.forename: Mokhtar
authors.initials: M
authors.lastname: Mabrouk
mesh_terms: D000284:Administration, Oral; D000932:Antiemetics / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D017829:Granisetron / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D057230:Limit of Detection; D010226:Parabens / Q000032:analysis; D019999:Pharmaceutical Solutions; D011310:Preservatives, Pharmaceutical / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D020160:Sodium Benzoate / Q000032:analysis
chemical_list: D000932:Antiemetics; D017829:Granisetron; D007202:Indicators and Reagents; D010226:Parabens; D019999:Pharmaceutical Solutions; D011310:Preservatives, Pharmaceutical; D020160:Sodium Benzoate; C015358:methylparaben; C006068:propylparaben