Method Development and Validation for Simultaneous Estimation of Montelukast Sodium and Desloratadine by RP-HPLC

Abstract

A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the simultaneous estimation of Montelukast Sodium (MON) and Desloratadine (DES) in pharmaceutical dosage forms. The drugs were estimated using Hypersil BDS C18 (250 mm × 4.6 mm I.D., 5 μ particle size) column. The mobile phase composed of orthophosphoric acid and water in the ratio of 20:80 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 280 nm. The linearity range obtained was 10 -30 µg/ml for MON and 5 -15 µg/ml for DES with retention times of 2.929 min and 4.439 min for MON and DES respectively. The correlation coefficient values were found to be 0.999. Precision studies showed % RSD values less than 2% for both the drugs in all the selected concentrations. The percentage recoveries of MON and DES were in the range of 99.59% -99.82% and 99.60% -99.80% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.176 µg/ml, 0.587 µg/ml for MON and 0.087 µg/ml, 0.292 µg/ml for DES respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available tablet dosage forms.

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.…”

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“…Clinical studies have shown that Bilastine is as efficacious as other non-sedating antihistamines in allergic rhinoconjunctivitis and chronic urticaria in individuals from 12 are used to treat allergic rhinitis and mild to moderate asthma 6 . Literature review revealed that several methods for analyzing Bilastine and Montelukast Sodium either alone or with other drugs by RP-HPLC [7][8][9][10][11][12][13] , UPLC 14-16, and HPTLC 17, have been reported. UV Spectroscopic method19 has reported only one Method for simultaneous estimation of this combination and RP HPLC 20,21 .…”

Stability Indicating Quality by Design-based Development and Validation of Bilastine and Montelukast by Ultra Performance Liquid Chromatography Method

“…5 The quality project from the planning stage to the end of the product life cycle is addressed by the QbD tool. 6 The literature suggests that a number of analytical techniques, including UV Spectroscopy, [7][8][9][10] high-performance liquid chromatography (HPLC), [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] high-performance thin layer chromatography (HPTLC), 17 and ultra performance liquid chromatography (UPLC ) 18,19 for the simultaneous determination of BIL and MON, have been reported. Except for spectrophotometry, none of these technologies were applied for analytical QbD in the published literature.…”