Simultaneous estimation of esomeprazole and levosulpiride in solid dosage form

A simple, precise and highly selective analytical method was developed for simultaneous estimation of Esomeprazole 40 mg and Levosulpiride SR 75 mg in capsules dosage form. Estimation was carried out by multicomponent mode of analysis at selected wavelength of 277 nm and 283 nm for Levosulpiride and Esomeprazole respectively in methanol. The method was found to be linear in the range of 1-40 μg/ml for Levosulpiride and 1-30 μg/ml for Esomeprazole while accuracy of the method was confirmed by recovery studies of solid dosages forms and was found to be for batch-A 98.33% and 98.44% for Batch-B 99.24% and 98.77% for Levosulpiride and Esomeprazole respectively. Initially lab samples were utilized to validate developed method according to ICH guidelines followed by determination of % concentration of Levosulpiride and Esomeprazole in marketed formulation that was found to be for Batch-A 98.07 ±0.51 and 96.81± 0.51 for Batch-B 98.23 ±0.65 and 97.98± 0.65 respectively. The values of precision and robustness lie within acceptable limit. Thus the proposed method can be successfully applied for simultaneous determination of Levosulpiride and Esomeprazole respectively in routine analytical work.

Author(s): Yogesh P. Agrawal, Surya Prakash Gautam, Ajay Verma, Mona Y. Agrawal and Arun K. Gupta

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