کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1224060 967907 2008 4 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Development and validation of RP-HPLC method for the determination of genotoxic alkyl benzenesulfonates in amlodipine besylate
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Development and validation of RP-HPLC method for the determination of genotoxic alkyl benzenesulfonates in amlodipine besylate
چکیده انگلیسی

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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 48, Issue 1, 10 September 2008, Pages 227–230
نویسندگان
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