Sci. Pharm. 2012; 80: 77–87
Simple and Sensitive Stability-Indicating Ion Chromatography Method for the Determination of Cyclopropylamine in Nevirapine and Moxifloxacin Hydrochloride Drug Substances
Pavan Kumar S. R. KOTHAPALLI * 1, Mukkanti KHAGGA 2, Nageswara Rao MEKALA 1, John Prasanna SIGAMANI 1, Jagadeesh Kumar VUNDAVILLI * 1, Narendra Kumar MASANI 1, Hemant Kumar SHARMA 1
1 Aurobindo Pharma Limited Research Centre, 313, Bachupally, Hyderabad-500 090, Andhra Pradesh, India.
2 J. N. T. University, Kukatpally, Hyderabad-500085, Andhra Pradesh, India.
A simple and sensitive ion chromatography method has been developed for the determination of cyclopropylamine (CPA) in nevirapine (NEV) and moxifloxacin HCl (MOX) pharmaceutical drug substances. Efficient chromatographic separation was achieved on a Metrosep C4, 5 μm (250 mm x 4.0 mm) column. The mobile phase consists of 5 mM hydrochloric acid containing 10% (v/v) acetonitrile and was delivered in an isocratic mode at a flow rate of 0.9 mL min−1 at 27°C. A conductometric detector was used for the detection of the analyte. The drug substances were subjected to stress conditions including oxidation, thermal, photolytic and humidity for the evaluation of the stability-indicating nature of the method. The method was validated for specificity, precision, linearity, accuracy and solution stability. The limit of detection (LOD) and limit of quantification (LOQ) values are 0.10 μg mL−1 and 0.37 μg mL−1 respectively. The linearity range of the method is between 0.37 μg mL−1 and 1.5 μg mL−1 and the correlation coefficient is found to be 0.9971. The average recoveries of CPA in NEV and MOX are 97.0% and 98.0%, respectively.
Ion chromatography • Cyclopropylamine • Nevirapine • Moxifloxacin hydrochloride • Validation • Stress conditions
Received July 12th, 2011 | Accepted October 20th, 2011 | Published Online October 20th, 2011