Development and validation of RP-HPLC method for the determination of genotoxic alkyl benzenesulfonates in amlodipine besylate

The present paper describes a simple isocratic reverse phase HPLC method for the determination of four genotoxic alkyl benzenesulfonates (ABSs) viz. methyl, ethyl, n-propyl and isopropyl benzenesulfonates (MBS, EBS, NPBS and IPBS) in amlodipine besylate (ADB). Good resolution between benzene sulfoni...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2008-09, Vol.48 (1), p.227-230
Main Authors: Raman, N.V.V.S.S., Reddy, K. Ratnakar, Prasad, A.V.S.S., Ramakrishna, K.
Format: Article
Language:English
Subjects:
Alkyl benzenesulfonates
Amlodipine - analysis
Amlodipine besylate
Analysis
Analytical, structural and metabolic biochemistry
Antihypertensive Agents - analysis
Benzenesulfonates - analysis
Benzenesulfonates - chemistry
Benzenesulfonates - toxicity
Biological and medical sciences
Chromatography, High Pressure Liquid - methods
Development
Fundamental and applied biological sciences. Psychology
General pharmacology
Genotoxins
Guidelines as Topic
Medical sciences
Molecular Structure
Mutagens - analysis
Pharmacology. Drug treatments
Reproducibility of Results
Sensitivity and Specificity
Validation
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Summary:The present paper describes a simple isocratic reverse phase HPLC method for the determination of four genotoxic alkyl benzenesulfonates (ABSs) viz. methyl, ethyl, n-propyl and isopropyl benzenesulfonates (MBS, EBS, NPBS and IPBS) in amlodipine besylate (ADB). Good resolution between benzene sulfonic acid (BSA), MBS, EBS, NPBS, IPBS and ADB was achieved with Inertsil ODS 3V (150 mm × 4.6 mm, 5 μm) column using a 65:35 (v/v) mixture of 1% triethyl amine, pH adjusted to 3.0 with orthophosphoric acid and acetonitrile as mobile phase. The flow rate was 1.0 ml/min and the elution was monitored at 220 nm. The factors involved in the method development are discussed. This method was validated as per International Conference on Harmonization (ICH) guidelines and is able to quantitate MBS, EBS, NPBS and IPBS at 21, 32, 35 and 28 ppm levels, respectively with respect to 5 mg/ml of ADB. The method is linear in range of 75–180 ppm of ABSs, which matches the range of 50–120% of estimated permitted level (150 ppm) of ABSs. ABSs were not present in the three studied pure and tablet batches of ADB.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2008.05.021