High performance liquid chromatographic method development for simultaneous analysis of doxofylline and montelukast sodium in a combined form

Abstract

Aim:Some literatures revealed that the high performance liquid chromatography (HPLC) method for single component or multicomponent analysis of montelukast sodium with other drugs. However, these methods deals with time consuming, so it is necessary to develop a cost-effective and less time consuming method for the estimation of doxofylline and montelukast sodium in combined pharmaceutical formulation.Materials and Methods:The separation was performed on an inertsil C8 (5 μm, 4.6 × 250 mm) column in isocratic mode with the mobile phase consisting a mixture of methanol and sodium phosphate buffer (75:25 v/v, pH 6.5 adjusted with orthophosphoric acid). The mobile phase was pumped at a flow rate of 1 mL min-1 and eluents were monitored at 230 nm.Results:The selected chromatographic conditions were found to separate doxofylline (retention time = 3.4 min) and montelukast sodium (retention time = 5.5 min) with a resolution of 5.47. The proposed HPLC method was validated with respect to linearity, accuracy, repeatability, specificity, robustness, and ruggedness as per International Conference on Harmonisation guidelines Q2(R1), November 2005 (Validation of Analytical Procedures: Text and Methodology). The percentage recoveries for doxofylline and montelukast sodium ranged from 98.1% to 101.7% and 98.2 to 101.9%, respectively, which indicated that the above method was enough accurate and precise.Conclusions:Hence, it was concluded that the developed method is suitable for routine analysis of these combination due to its less analysis time.

Development of RP-HPLC Method for Simultaneous Determination of Bilastine and Montelukast by Qbd Approach and Its Validation

“…And software suggested the optimized ratio of the mobile phase is (80:20), which is closer to our actual experimental ratio, i.e. (85:15) [35][36][37] . Experimental data obtained for both trials approximately matches the data provided by DOE software which shows the authenticity of the chromatographic condition.…”

Development of Pharmaceutical Equivalent Montelukast Sodium Immediate-Release, Film-Coated Tablets

“…Even though there are official methods for analyzing montelukast sodium in pharmacopoeias or research articles, we have an expedient in-house procedure that we employ for this study (Singh et al, 2010;Rashmitha et al, 2010;United States Pharmacopeial, 2023). The analytical method of montelukast sodium using HPLC was validated according to the ICH guidelines (Eldin et al, 2011;Singh et al, 2010;Ethiraj et al, 2011). Figure 2 displays the chromatogram of montelukast sodium in the standard solution, tablet sample, and excipient signal.…”

An analytical review for the estimation of montelukast sodium

“…According to ICH guidelines, the proposed HPLC method by Revathi et al. was validated and good linearity, accuracy, repeatability, and precision were found [41].…”

“…The selected chromatographic condition was found to separate doxofylline and MONTE accordingly (retention times: 3.4 and 5.5 min, respectively), and percent recoveries ranged from 98.1 to 101.9%, respectively. According to ICH guidelines, the proposed HPLC method by Revathi et al was validated and good linearity, accuracy, repeatability, and precision were found [41].…”