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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.

A validated liquid chromatography and tandem mass spectrometric method for simultaneous quantitation of tenofovir, emtricitabine, and efavirenz in human plasma and its pharmacokinetic application

Matta M. K, Pilli N. R, Rao J.V.L.N. S.

Acta Chromatographica

2015

Vol. 27, no. 1

27--39

A novel, rapid, and sensitive liquid chromatography-tandem mass spectrometric method was developed and validated for the simultaneous quantification of tenofovir, emtricitabine, and efavirenz in human plasma. Nevirapine was used as an internal standard. The analytes and the internal standard were extracted from human plasma sample by solid-phase extraction technique (SPE). The reconstituted samples were chromatographed on a Chromolith ROD C18 column (50 × 4.6 mm; 5 μ) by gradient elution using a mixture of ammonium acetate buffer (5 mM) and 0.1% formic acid in acetonitrile as the mobile phase at a flow rate of 1.0 mL min -1. The calibration curve obtained was linear (r2 ≥ 0.9990) over the concentration range of 2.5–650 ng mL -1 for tenofovir and 10–4000 ng mL -1 for emtricitabine and efavirenz. The results of the intra- and inter-day precision and accuracy studies were well within the acceptable limits. A run time of 2.5 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies, and the authenticity in the measurement of clinical data is demonstrated through incurred samples reanalysis (ISR).