GET THE APP

Designing of forced degradation studies and development of validated stability indicating method for simultaneous estimation of desloratadine and montelukast odium in their formulation | Abstract
Scholars Research Library

Scholars Research Library

A-Z Journals

+44 7389645282

Der Pharmacia Lettre

Abstract

Designing of forced degradation studies and development of validated stability indicating method for simultaneous estimation of desloratadine and montelukast odium in their formulation

Author(s): Sk. Mastanamma, G. Rambabu, P. Saidulu and I. S. Tejaswini

A simple, rapid, accurate, precise and validated high performance liquid chromatographic method for simultaneous estimation of Desloratadine(DES) and Montelukast sodium(MKT) in bulk and pharmaceutical formulation. The RPHPLC was performed on YMC C18 column (250, 4.6I’d, 5μm particle size) column with mobile phase Orthophosporic acid (pH-2.1): Methanol (40:60v/v) and column temperature 30oC. The flow rate of the mobile phase was adjusted to 1ml/min and the injection volume was 10μl.Detection was performed at 278nm.The Retention time for DES and MKT were 3.504 and 4.724 min respectively. The method was validated and shown to be linear for DES and MKT in 5-15 μl and 10-30 μl respectively. Both the drugs have the regression 0.999.DES was highly susceptible to Oxidation and least susceptible to Basic condition MKT was susceptible to acidic condition. The relative standard deviation of DES and MKT for intra-day was 0.24% and 0.11%respectively,inter day was found 0.25% and 0.12% respectively. The Developed RP-HPLC method is suitable for estimation of Desloratadine and Montelukast sodium in tablet formulation. Hence this method can be used in quality control for routine analysis of the finished product.