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Validated Stability-Indicating Reversed-Phase-HPLC Method for Simultaneous Determination of Orphenadrine Citrate, Caffeine and Aspirin
Faculty
Pharmacy
Year:
2012
Type of Publication:
Article
Pages:
1426-1436
Authors:
Mostafa, Samia, Salama, Ismail, El-Sadek, Mohamed, Darwish, Khaled
Journal:
CHEMICAL \& PHARMACEUTICAL BULLETIN PHARMACEUTICAL SOC JAPAN
Volume:
60
Research Area:
Pharmacology \& Pharmacy; Chemistry
ISSN
ISI:000310662600011
Keywords :
stability-indicating, orphenadrine citrate, caffeine, aspirin, reversed-phase HPLC, pharmaceutical formulation (tablet)
Abstract:
New, simple, rapid and precise reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of orphenadrine citrate, caffeine and aspirin in presence of aspirin degradation products, orphenadrine citrate and caffeine process related impurities, and excipients. Good resolution and quantization were achieved on reversed-phase column {[}Phenomenex (TM) Luna ODS C-18 (25cmx4.6mm, 5 mu m particles)]. Gradient elution based on; eluant {[}A]: 0.1\% triethylamine in aqueous potassium dihydrogen phosphate buffer (50mm; pH 3.0), while as, eluant acetonitrile, at a flow rate of 1.5 mL min(-1). UV quantitation was set at 215nm. Linearity was exhibited for orphenadrine citrate, caffeine and aspirin within 0.5-150, 0.5-360 or 0.7-301 mu g mL(-1) ranges, respectively. Satisfactory validation results were ascertained in terms of low limits of quantiation (6.33x10(-2)-7.94x10(-2)), mean percentage recovery (98.9-101.4\%), precision (<2\%) and robustness. The proposed method was proved to be specific, robust and accurate for the determination of cited drugs in pharmaceutical preparations in presence of their degradation products.
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