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Assessment of the greenness of micellar HPLC method for rapid separation and simultaneous estimation of chlorpheniramine maleate in presence of some co-administered drugs in three pharmaceutical dosage forms using single run

Nasr Zeinab Adel, Soliman Marwa M., Mohamed Ekram H., Fouad Fatma A.

Acta Chromatographica

2022

Vol. 34, no. 2

138--149

Sustainable chemistry established one of kind standards to maintain protection of environment through using safer mobile phase composition and/or lower solvent consumption. A fast green micellar HPLC method was developed and applied for the first time aiming at simultaneous determination of chlorpheniramine maleate, one of the most widely used antihistamine in combination with levochlopersatine fenodizoate or dextromethorphan hydrobromide or dexamethasone, in their pure forms, laboratory prepared mixtures and pharmaceutical dosage forms used in alleviating the symptoms of cough resulting from common colds and allergy. The separation was achieved on Kinetex C18 column (100 mm34.6 mm i.d., 2.6-mm particle size) using micellar aqueous mobile phase consisting of (30 mM sodium dodecyl sulfate and 50 mM sodium dihydrogen phosphate, pH 5) and ethanol (85:15) with UV detection at 230 nm. The four drugs were successfully separated using isocratic elution in a single run not exceeding 7 min. According to ICH guidelines, the method was confirmed to be linear, accurate and precise over the concentration ranges of 5–60 mg mL1 for chlorpheniramine maleate, 10–100 mg mL1 for levocloperastine fenodizoate and dextromethorphan hydrobromide and 5–30 mg mL1 for dexamethasone. In addition, the greenness of the developed method was assessed using two different tools indicating their least hazardous effect on the environment.

Simultaneous determination of levocetirizine dihydrochloride and montelukast sodium in human plasma by LC–MS/MS: development, validation, and application to a human pharmacokinetic study

Rashed Noha Salem, Nasr Zeinab Adel

Acta Chromatographica

2019

Vol. 31, no. 3

194--200

Objectives: A simple, rapid, selective, and sensitive high-performance liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was developed for the simultaneous determination of levocetirizine dihydrochloride and montelukast sodium in human plasma using fexofenadine hydrochloride as an internal standard. Method: Liquid–liquid extraction of both drugs and internal standard from plasma into ethyl acetate was used for sample preparation and analysis. Separation of both drugs and internal standard was achieved on an Inertsil ODS-3 (4.6 mm × 50 cm, dp 5 μm, particle size) column using an isocratic mobile phase of acetonitrile and 10 mM ammonium formate adjusted to pH 8 with 50 μL ammonium hydroxide in composition of 73:27 (v/v) at a flow rate of 0.7 mL/min. The LC–MS/MS was operated under the multiple reaction monitoring mode (MRM) using an electrospray ionization technique. Mass parameters were optimized to monitor transitions at m/z [M + H]+ 389.0 → 200.8 for levocetirizine dihydrochloride, m/z [M + H]+ 586.2 → 422.2 for montelukast sodium, and m/z [M + H]+ 502.2 → 466.0 for fexofenadine hydrochloride. Results: The method was found to be linear in the range of 1–500 ng/mL for both drugs. The intra-day and inter-day precision were in the range of 0.96–1.92% and 1.03–1.55%, respectively. Matrix effect was acceptable with %RSD < 15. Conclusion: The proposed method was validated and successfully applied for a pharmacokinetic study of both drugs in human plasma after oral administration of their pharmaceutical preparation.