Mon, 18 Dec 2017

Stability Indicating RP-HPLC Method for Quantitative Estimation of S (-) Metoprolol Succinate in Tablet Dosage Form

Suresh V. Shitole*1, Mukund Gurjar1, Mahesh Shah1, Gobardhan Bal1, Srikant Pimple1, Rahul Patel1

1. R & D- Analytical, Emcure Pharmaceuticals Ltd, Bhosari, Pune 411026, India


ABSTRACT

A simple, precise, rapid and specific reversed phase high performance liquid chromatographic method for determination of S (-) Metoprolol Succinate was developed and validated. The chromatographic separation was achieved on Inertsil ODS column (125×4.6mm, 5µ), using a mixture of 20mM potassium dihydrogen phosphate (pH adjusted to 3.5 with ortho-phosphoric acid) and acetonitrile as mobile phase in the ratio of 80:20 at flow rate of 1.5 mL/min. The detection was performed at 220 nm. The calibration curve was linear in the range of 30 - 90 µg/mL (r2 = 0.99999). Major impurities and degradation products were well separated from S(-) Metoprolol Succinate. Thus this assay method can be considered as stability-indicating.

Keywords: S (-) Metoprolol Succinate, Stability-indicating assay, RP-HPLC.

 


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