Development and Validation of RP-HPLC Method for Simultaneous Estimation of Montelukast and Rupatadine in Pharmaceutical Dosage Form

Research Article

Austin J Anal Pharm Chem. 2018; 5(1): 1094.

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Montelukast and Rupatadine in Pharmaceutical Dosage Form

Bangale G*, Ambhore J and Paikrao S

¹Department of Pharmaceutics, Government College of Pharmacy, Amravati, India

*Corresponding author: Ganesh S. Bangale, Government College of Pharmacy, Amravati, India

Received: December 30, 2017; Accepted: February 01, 2018; Published: February 08, 2018

Abstract

The aim of the present study was the development and validation of a simple, precise, and specific RP-HPLC method for assay of Montelukast (MNT) and Rupatadine (RPT) in tablet dosage forms. The separation was achieved on Grace C-18 Column (4.6 × 250mm, 5µm) using Acetonitrile and 0.05% OPA (60:40, v/v) as mobile phase for assay and flow rate 1ml/ min & detection was carried out in U.V detector at 242.0nm. The retention time of RPT and MNT were found to be 3.86min and 7.60min respectively. The linearity of the RPT and MNT was found over the range of 5-25µg/ml. The system suitability test shows the response with retention time, theoretical plate, tailing factor and peak area for both the drugs. The validation of method carried out using ICH guidelines. The developed method was gave good resolution for drugs. The developed RPHPLC method can be applied for routine quantitative and qualitative analysis of RPT and MNT in bulk and pharmaceutical formulations like tablets.

Keywords: Rupatadine; Montelukast; RP-HPLC; Validation; Actonitrile

Introduction

Rupatadine is a second generation antihistamine and PAF antagonist used to treat allergies. Rupatadine fumarate has been approved for the treatment of allergic rhinitis and chronic urticaria in adults and children over 12 years. The defined daily dose (DDD) is 10mg orally. It is soluble in methanol and ethanol slightly soluble in Chloroform and insoluble inwater. It is off white to pinkish crystalline powder. Montelukast is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Montelukast is a CysLT1 antagonist; it blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. It is off white hygroscopic powder. It is freely soluble in ethanol, methanol and water [1,2]. The development of analytical method for the determination of drugs in bulk, in dosage forms or in body fluids has received attention in recent years because of their importance in quality control, bioavailability and pharmacokinetic study. Literature review reveals that few analytical methods were evoked for the estimation of rupatadine fumarate and montelukast sodium, the present work is an attempt to estimate the same in combination by different method such as RPHPLC method (Figure 1 and 2) [3,4].