RP-HPLC-PDA Method for Simultaneous Quantification of Montelukast, Acebrophylline and Desloratadine Tablets

Abstract

A simple, fast, accurate and specific RP-HPLC-PDA method has been developed for the simultaneous quantification of montelukast, acebrophylline and desloratadine in bulk and tablet dosage form. The chromatographic separation was performed on a reverse phase BDS C8 Column (150 × 4.6mm, 5 µm particle size) consisting mobile phase of potassium hydrogen ortho-phosphate buffer:acetonitrile (40:60 v/v), with a flow rate 1 mL/min, temperature 30 ºC and UV detection wavelength 280 nm. The retention times of montelukast, acebrophylline and desloratadine were observed as 2.04, 2.68 and 3.77 min, respectively. The developed method was validated by validation parameters such as linearity, range, accuracy, precision and robustness. The results obtained for validation parameters are within the limits as per ICH guidelines. The linearity of the drugs were obtained in the range of 5-30 ppm for montelukast, 100-600 ppm acebrophylline and 2.5-15 ppm for desloratadine. % RSD from precision studies were 0.4, 0.1 and 1.0 mean percentage recovery from accuracy studies were found to be 98.47, 98.71 and 100.11 for montelukast, acebrophylline and desloratadine respeactively. Limit of detection values were found as 0.01, 0.32 and 0.01 for montelukast, acebrophylline and desloratadine, respectively. Limit of quantification values were found as 0.03, 0.98 and 0.04 montelukast, acebrophylline and desloratadine, respectively. The method designed and validated can be successfully used for the regular quantification of montelukast, acebrophylline and desloratadine in tablet and bulk forms.

Validated Spectrophotometric Methods for Determination of Montelukast Sodium in Pure and Dosage Forms Using N-Bromosuccinimide and Dyes

“…The literature survey revealed that few methods were described for the determination of MNT in pure, tablet dosage forms and biological fluids such as spectrofluorimetry [2], electrochemical [3], electrophoresis [4,5] and high-performance liquid chromatography [6][7][8][9][10][11][12][13]. Most of these reported methods are either not appropriately sensitive or tedious and utilized expensive instruments that are not available in most quality control laboratories.…”

Development and Validation of Rp-HPLC Method for the Simultaneous Estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in Bulk and Tablet Dosage Forms

“…Some of the literature was available for the combination of Sofosbuvir and Velpatasvir. [4][5][6][7][8] No literature available for the estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in a combined dosage form. Sofosbuvir(400mg), Velpatasvir(100mg) and Voxilaprevir(100mg) were available in a mixed dose form of VOSEVI.…”

“…The US FDA was approved in 2017. The HPLC technique was used for the development and validation of combinational drugs were reported [4][5][6][7][8][9] . But no method was found for the estimation of …”

Analytical method development and validation for the simultaneous estimation of montelukast and Acebrophylline by RP- HPLC method

“…It is mainly involved in the qualitative identification or detection of compounds and quantitative measurements of the substances present in bulk and pharmaceutical preparation. The technique employed in quantitative analysis is based upon the quantitative performance of suitable chemical reactions and either measuring the amount of reagent needed to complete the reaction, or ascertaining the amount of reaction product obtained [1]. Quality is important in every product or service but it is vital in medicine as it involves life.…”