Simultaneous estimation of esomeprazole and levosulpiride in bulk and in capsule formulation by rp-hplc

• RAKESHR JAIN ^[1] ; PRAVINO PATIL ^[1] ; SANJAYB BARI ^[1]
  1. [1] H.R. Patel Institute of Pharmaceutical Education and Research Department of Quality Assurance
• Localización: Journal of the Chilean Chemical Society (Boletín de la Sociedad Chilena de Química), ISSN-e 0717-6309, ISSN 0366-1644, Vol. 58, Nº. 3, 2013, págs. 1846-1849
• Idioma: inglés
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  • The present work deals with development and validation for simultaneous determination of Esomeprazole and Levosulpiride drugs in pharmaceutical formulations. A rapid, precise and specific reverse phase high performance liquid chromatography (RP-HPLC) method was developed for Esomeprazole and Levosulpiride. Chromatographic separations was achieved on a C-18 (5μm, 250x4.6 mm) HPLC column within a runtime of 10 min. Isocratic mobile phase contain methanol: buffer (pH 3) (65:35% v/v) and flow rate was maintained at 1.0 mL/min. Eluate was monitored at 260 nm. Levosulpiride was eluated at 2.7 min and Esomeprazole at 5.7 min. Linearity was studied in the concentratiosn range of 5 to 30 μg mL-1 and 10 to 60 μg/ mL for esomeprazole and levosulpiride respectively, with a correlation coefficient of 0.9995 and 0.9993 respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.