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.
Highlights
Montelukast Sodium (MON) (Figure 1) is chemically 2-[1-({[(1R)-1-{3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl] phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl} methyl)cyclopropyl]acetic acid [1]
MON inhibits the actions of leukotriene D4 (LTD4) at the CysLT1 receptor, preventing airway edema, smooth muscle contraction and enhanced secretion of thick, viscous mucus [4]-[7]
Literature survey reveals that few analytical methods are available for the simultaneous estimation of MON and DES in pharmaceutical formulations by using UV [9]-[11] and HPLC [12]-[15]
Summary
Montelukast Sodium (MON) (Figure 1) is chemically 2-[1-({[(1R)-1-{3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl] phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl} methyl)cyclopropyl]acetic acid [1]. MON selectively antagonizes leukotriene D4 (LTD4) at the cysteinyl leukotriene receptor, CysLT1, in the human airway. DES is a second generation, tricyclic antihistamine that which has a selective and peripheral H1-antagonist action [4]. It is the active descarboethoxy metabolite of Loratidine. Literature survey reveals that few analytical methods are available for the simultaneous estimation of MON and DES in pharmaceutical formulations by using UV [9]-[11] and HPLC [12]-[15]. We made an attempt to develop a simple method for the simultaneous estimation of MON and DES by RP-HPLC in pharmaceutical dosage forms. The proposed method was optimized and validated as per the International Conference on Harmonization (ICH) guidelines [16]
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