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 × 4.6 mm id, 3.5 μm 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.

Characteristic Profiles of Urinary p-Hydroxybenzoic Acid and its Esters (Parabens) in Children and Adults from the United States and China

“…Parabens are widely present in foodstuffs, , cosmetics, and pharmaceuticals . Further, parabens have been reported to occur in indoor environments, − wastewater treatment plant discharge and surface water .…”

“…2 Parabens are widely present in foodstuffs, 16,17 cosmetics, 18 and pharmaceuticals. 19 Further, parabens have been reported to occur in indoor environments, 20−22 wastewater treatment plant discharge and surface water. 23 In 2006, Ye et al 24 reported MeP and PrP in urine from U.S. adults (n = 100), at median concentrations of 43.9 and 9.1 ng/mL, respectively.…”

HPLC: Highly Accessible Instrument in Pharmaceutical Industry for Effective Method Development

“…Extraction sorbents for on-line SPE extend to an array of media including large particles for turbulent flow chromatography, restricted access materials (RAM), monolithic materials and disposable cartridges utilizing traditional packing's such as those used in Spark Holland systems. In the end, this paper also discusses recent studies of matrix effect in LC-MS/MS analysis and how to reduce/eliminate matrix effect in method development and validation [32][33][34].…”

In situ polymerization and FT-IR characterization of poly-glycine on pencil graphite electrode for sensitive determination of anti-emetic drug, granisetron in injections and human plasma

“…Various analytical methods were reported for quantitative determination of GRN in bulk, different pharmaceutical and biological samples, as spectrophotometric, 14,15 spectro-uorimetric, 16 HPTLC, 17,18 and HPLC [19][20][21][22] methods. Electrochemical techniques are widely used nowadays for their high sensitivity, selectivity, cost effective and high sample throughput within short analysis time.…”