Original Articles: 2011 Vol: 3 Issue: 6
Development and Validation of RP-HPLC Stability-Indicating Methods for the Determination of Butamirate Citrate and Sodium Cromoglycate
Two novel high performance liquid chromatographic (HPLC) methods are presented for the determination of butamirate citrate (BC) and sodium cromoglycate (NaCr) in the presence of or with their degradation products. The first method was based on RP-HPLC separation of BC from its degradation product using an Agilent Zorbax ODS (C18) column with a mobile phase consisting of methanol: acetonitrile: water (100: 75: 25, v/v/v) adjusted with triethylamine to pH 9.8±0.1 with UV detection at 225 nm and using clobutinol hydrochloride (CH) as internal standard. The second method was based on HPLC separation of NaCr from its degradation product using an Agilent Zorbax ODS (C18) column with a mobile phase consisting of methanol: water (75: 25, v/v) using metronidazole (MT) as internal standard. Quantification was achieved with UV detection at 254 nm. The developed methods were applied for the determination of BC or NaCr in their pharmaceutical formulations. Both methods proved stability indicating power but in the second one, the degradation product could be evaluated along with the intact NaCr. The developed methods were validated as per ICH guidelines and were also; suitable for assay determination of the cited drugs in pharmaceutical dosage forms.