Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF MIDODRINE HYDROCHLORIDE ORAL SOLUTION

Nilam Pramod Nile*, Vanita Lokhande and Bhawar S. B.

ABSTRACT

A simple, accurate, sensitive and precise stability indicating Reverse Phase- High Performance Liquid Chromatographic assay method for estimation of Midodrine hydrochloride oral solution was successfully developed. The chromatographic separation was performed on Inertsil ODS 3V C18, 5μ, 4.6 x 150mm column. The mobile phase A consists of of pH-4.0 phosphate buffer with TEA and B consist of acetonitrile. Gradient was delivered at a flow rate of 1.0 ml/min. Samples were injected 20 μL the column temperature was kept at 25 0 C and sample temperature 10 0 C. The wavelength 290 nm were selected for the evaluation of the chromatogram. The retention time of the drug was found to be 3.7 min. The developed method was found to be linear in a concentration range of 124.8-374.6 μg/ml of the drug (r 2 = 1.000). The low value of % RSD indicates reproducibility of the method. The results of forced degradation studies indicated that the drug was stable in Photolytic condition and degraded in acidic, basic, oxidative and thermal conditions. The method was validated with forced degradation studies as per ICH guidelines. Thus this method can be used for routine analysis of Midodrine hydrochloride formulation and to check the stability of bulk samples.

Keywords: Midodrine hydrochloride, RP-HPLC, Method validation, Stability indicating assay method.