Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations

A simple and rapid reversed phase liquid chromatographic method for separation and determination of the related substances of telmisartan (TLM) was developed and validated. The chromatographic separation was achieved on Lichrospher RP-18 column (250×4.6mm, 5μm), using 20mM ammonium acetate containin...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2011-11, Vol.56 (3), p.471-478
Main Authors: Nageswara Rao, R., Guru Prasad, K., Gangu Naidu, Ch, Maurya, Pawan K.
Format: Article
Language:English
Subjects:
acetonitrile
Acetonitriles - analysis
Acetonitriles - chemistry
ammonium acetate
Analysis
Analytical, structural and metabolic biochemistry
Benzimidazoles - analysis
Benzimidazoles - chemistry
Benzoates - analysis
Benzoates - chemistry
Biological and medical sciences
Bulk drugs
Chemistry, Pharmaceutical - methods
Chromatography, Liquid - methods
detection limit
Drug Contamination
Ethylamines - analysis
Ethylamines - chemistry
Fundamental and applied biological sciences. Psychology
General pharmacology
Hypertension
Medical sciences
Pharmacology. Drug treatments
Quality Control
Related substances
Reproducibility of Results
reversed-phase liquid chromatography
RP-HPLC
Tablets - analysis
Tablets - chemistry
Telmisartan
triethylamine
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Summary:A simple and rapid reversed phase liquid chromatographic method for separation and determination of the related substances of telmisartan (TLM) was developed and validated. The chromatographic separation was achieved on Lichrospher RP-18 column (250×4.6mm, 5μm), using 20mM ammonium acetate containing 0.1% (v/v) triethylamine (pH adjusted to 3.0 with trifluoroacetic acid) and acetonitrile as mobile phase at 25°C. The detection was performed at 254nm. The method was validated and found to be robust, precise, specific and linear between 0.37 and 500μg/mL. The limits of detection and quantification of telmisartan were 0.11 and 0.37μg/mL, respectively. The method was successfully applied to quantify related substances and assay of TLM in bulk drugs and commercial tablets. The related substances relate to a novel synthetic route and different from those A-H impurities reported by European Pharmacopeia.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2011.05.043