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Transfer of TLC screening methods to quantitative HPTLC–densitometry methods for pharmaceutical products containing amlodipine besylate, cefpodoxime proxetil, cetirizine 2HCl, diclofenac sodium, efavirenz, mefenamic acid, and atovaquone + proguanil HCl

Zeng B., Gu Y., Sherma J.

Acta Chromatographica

2019

Vol. 31, no. 4

246--249

Transfer of seven thin-layer chromatography (TLC) Global Pharma Health Fund E.V. Minilab protocols for screening counterfeit pharmaceutical products in the field to quantitative high-performance TLC (HPTLC)–densitometry methods was performed using a model process published previously. The developed and validated methods for tablets containing amlodipine besylate, cefpodoxime proxetil, cetirizine 2HCl, diclofenac sodium, efavirenz, mefenamic acid, and atovaquone + proguanil HCl involved the use of only relatively inexpensive and nontoxic solvents, Merck KGaA Premium Purity HPTLC silica gel 60 F254 plates, semi-automated sample and standard solution application with a CAMAG Linomat 4, and automated densitometry with a CAMAG Scanner 3 for detection, identification, and quantification. In addition, previously transferred HPTLC–densitometry methods for azithromycin and for cephalexin were used to analyze a new product of each drug to demonstrate the applicability of the methods.

Simultaneous analysis of ambroxol HCl with cetirizine HCl and of ambroxol HCl with levo -cetirizine dihydrochloride in solid dosage forms by RP-HPLC

Birajdar A. S., Meyyanathan S. N., Raja R. B., Krishanaveni N., Suresh B.

Acta Chromatographica

2008

Vol. 20, no. 3

411-421

An isocratic RP-HPLC method has been developed and validated for simultaneous analysis of ambroxol hydrochloride (AMB) with cetirizine hydrochloride (CTZ) and of ambroxol hydrochloride (AMB) with levo -cetirizine dihydrochloride (LCTZ) in combined solid dosage forms. Formulations containing AMB with CTZ (tablets) and AMB with LCTZ (capsules) are used as antihistaminic H 1 blockers. Chromatography was performed on a 250 mm × 4.6 mm, 5-µm particle size, C 18 (ODS) column with a 45:30:30 ( v/v ) mixture of 30 mM aqueous ammonium sulphate (pH 5.5), acetonitrile, and methanol as mobile phase at a flow rate of 1 mL min -1 . The detection wavelength was 230 nm and analysis was performed at room temperature. Hydrochlorothiazide was used as internal standard for both formulations. Plots of drug-to-internal standard peakarea ratios (response factor) against respective concentrations were linear in the range 3 to 20 µg mL -1 for AMB and in the range 1 to 11 µg mL -1 for CTZ and LCTZ. The method was precise (RSD < 2) and accurate for analysis of both drugs in pharmaceutical dosage forms. Statistical data and results from recovery studies were reported for both formulations.