Journal of Developing Drugs
Open Access
ISSN: 2329-6631
+44 1478 350008
ISSN: 2329-6631
+44 1478 350008
Krishna Veni Nagappan
JSS College of Pharmacy- Jagadguru Sri Shivarathreeswara University, India
Posters & Accepted Abstracts: J Develop Drugs Res
A rapid, selective and reliable RP HPLC method has been developed for separating levosulpiride from its degradation products and the oxidative degradation product formed was characterised by HR MS/MS analysis. Levosulpiride, the levorotatory enantiomer of the sulpiride is a substantial benzamide derivative. It is chemically Nâ��[[(2S)-1-Ethylpyrrolidin- 2-yl]methyl]-2-ethoxy-5-sulfamoyl benzamide. It is a selective DA2 receptor blocker at the proximal tract and the chemoreceptor zone. It acts as a prokinetic agent blocking the inhibition and hence allows the cholinergic induced smooth muscle contraction in the myentric plexus. The separation was carried out on a Hibar C18 (250 mm x 4.6 mm, 5�¼) column using 10 mM Ammonium Acetate and acetonitrile in the ratio of 20:80% v/v as mobile phase at a flow rate of 1.0 mL/min. The column effluents are monitored by a photodiode array detector at 241 nm. The developed method was validated for accuracy, precision, linearity and range, detection/quantitation limits, specificity/selectivity, robustness and ruggedness. Stress degradation of levosulpiride was performed under acidic, basic, thermal and oxidative conditions. The major degradation product formed under the oxidative condition was isolated by semi preparative HPLC method. The isolated degradation product (LD1) was further characterized by HR-MS/MS analysis and the fragmentation pathway was proposed.