Development and validation of thin-layer chromatographic methods for quality control of herbal products (original) (raw)

2009, Acta Chromatographica

Artemisinin-based combination therapies (ACTs) are recommended for the treatment of uncomplicated falciparum malaria. Artemisinin derivatives are potent, rapidly acting antimalarias that reduce gametocyte carriage and patient infectivity; the sustained use of artesunate-amodiaquine reduced falciparum malaria transmission and progression of drug resistance. High efficacy of artemisinin-based combinations (artesunate plus amodiaquine) was observed in areas where malaria is endemic. This paper describes a routine, simple, precise, economical and reproducible thin layer chromatographic technique for the detection of artesunate and amodiaquine in tablet dosage form. Chromatographic separation was performed on glass silica gel plates (20 × 20 cm), paraffin-n-hexane (2:3 v/v) and ethylacetate-toluene (2.5:47.5 V/V) as mobile phases. Artesunate exhibited a detection limit of 0.001 mg/ml, while that of amodiaquine was 0.05 mg/ml. The two drugs were satisfactorily resolved with mean Rf values of 0.04 ± 0.03 and 0.06 ± 0.07 for artesunate and amodiaquine, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (0.001-6.0 and 0.05-6.0 mg/ml for artesunate and amodiaquine), precision (intraday RSD 10.68-25.78% and interday RSD 10.68-20.17 for artesunate, and intraday RSD 8.25-37.26% and inter day RSD 8.25-19.74% for amodiaquine) and specificity, in accordance with International Conference for Harmonization (ICH) guidelines. The method developed can be used for the analysis of ten or more formulation on a single plate and is a rapid and cost-effective quality-control tool for routine analysis of artesunate and amodiaquine as the parent drug and in tablet formulations.

Sign up for access to the world's latest research.

checkGet notified about relevant papers

checkSave papers to use in your research

checkJoin the discussion with peers

checkTrack your impact