International Journal of Advances in Pharmaceutical Analysis IJAPA Vol. 2 Issue 2 (2012) 41-46 Journal Home Page http://www.ssjournals.com/index.php/ijapa Corresponding Author*: usmangani84@gmail.com 41 DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF LEVOSULPIRIDE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM Chhalotiya Usmangani K. *1 , Bhatt Kashyap K 1 ., Shah Dimal A. 1 , Baldania Sunil L. 1 , Patel Jigar R. 2 *1 Indukaka Ipcowala College of Pharmacy, Beyond GIDC Phase IV, Vithal Udyognagar, New Vallabh Vidyanagar -388121, Anand, Gujarat, India. 2 Sun Pharmaceutical Industries Ltd, Baroda, Gujarat, India Abstract A rapid, specific and sensitive stability indicating reverse phase high performance liquid chromatographic method has been developed and validated for analysis of levosulpiride hydrochloride in both bulk and pharmaceutical dosage form. An isocratic stability indicating reversed-phase liquid chromatographic determination was developed for the quantitative determination of levosulpiride in the pharmaceutical dosage form. A sunfire C-18, 4.5µm column with mobile phase containing methanol-water (10:90, v/v) was used. The flow rate was 1.0 mL min -1 and effluents were monitored at 232 nm. The retention time of Levosulpiride was 5.5 min. Levosulpiride stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation, wet hydrolysis, dry heat degradation and sun light degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of Levosulpiride in tablet dosage forms. The proposed study describes stability indicating LC method for the estimation of Levosulpiride in bulk and their pharmaceutical dosage form. The method is suitable for the routine analysis of Levosulpiride in tablets. Keywords: Levosulpiride, Forced degradation, Reversed phase liquid chromatography, Validation. 1. Introduction Levosulpiride is a levo – enantiomer of racemic sulpiride belonging to the substituted benzamide group (Figure 1). It is a typical neuroleptic drug with sulpiride and inhibits dopaminergic D 2 receptors at the trigger zone both in central nervous system and in the gastrointestinal tract. Developed as an anti – emetic drug, sulpiride soon generated the interest for its antipsychotic properties and low potential to cause extra pyramidal side effect 1 . At low doses, sulpiride acts on pre-synaptic D 2 receptors and increase dopamine turn over in dopamine terminal area 2 , this effect produces a behavioral and generalized motor, mental arousal, which is therapeutically useful in depressed patients. At high doses, sulpiride exert its D 2 receptor blocking activity at both pre-synaptic and post-synaptic D 2 receptor sites, eliciting an antipsychotic effect. Levosulpiride acts on central nervous at lower doses than needed with sulpiride. Therefore, it is safe to use 3, 4 . Levosulpiride is a basic drug and has a low bioavailability 5 . Therefore, development of more effective analysis method is demanded for routine analysis in pharmaceutical dosage form. Several methods has been described in the literature, including UV – visible spectroscopy 6 , gas chromatography 7 , high performance liquid chromatography with ultraviolet, fluorescence 8,9 or mass spectrometric detection 10 and chiral HPLC method 11 . There has been published method for estimation of levosulpiride in human plasma by HPLC method 12 . Specially, stability indicting RP- HPLC method is routinely used for analysis of levosulpiride in pharmaceutical dosage form as per ICH guidelines 13, 14, 15, 16, 17 . Figure 1: Chemical structure of levosulpiride 2. Experimental 2.1 Apparatus: The liquid chromatographic system of waters (Calcutta, India) containing 515 HPLC isocratic pump, variable wavelength programmable 2998 photodiode array detector and rheodyne injector with 20 µl fixed loop was