Development and validation of a RP-HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form

Singh, Rohit; Saini, Pawan; Mathur, Satish C.; Singh, Gayatri; Lal, Basant

doi:10.4103/0250-474x.65023

Cited by 42 publications

(26 citation statements)

References 14 publications

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“…Literature review indicates that few analytical methods like spectrophotometric [3], HPLC [4][5][6][7] and LC-MS [8] have been reported for the quantification of montelukast with other drugs. Acebrophylline ( Fig.1) chemically is 4-[2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol; 2-(1,3-dimethyl-2,6-dioxopurin-7-yl)acetic acid.…”

Section: Montelukast (Fig 1) Chemically Is (1-[[[1r-1-[3-(1e)-2-(7-cmentioning

confidence: 99%

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

Mamatha¹,

Devanna²

2018

Asian J. Chem.

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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.

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Section: Montelukast (Fig 1) Chemically Is (1-[[[1r-1-[3-(1e)-2-(7-cmentioning

confidence: 99%

“…1) is a non-sedative antihistamine agent whose IUPAC name is 8-chloro-6,11-dihydro-11-(4-piperidi-nylidene)5H-benzo [5,6]cyclohepta [1,2-b]pyridine [19,20]. Desloratadine is partially soluble in water and completely soluble in ethanol [21].…”

Section: Montelukast (Fig 1) Chemically Is (1-[[[1r-1-[3-(1e)-2-(7-cmentioning

confidence: 99%

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

Mamatha¹,

Devanna²

2018

Asian J. Chem.

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“…The volume of injection loop was 20 μl prior to the injection of the drug solution; the column was equilibrated for at least 20 min. with the mobile phase 11 .…”

Section: Apparatus and Chromatographic Conditionmentioning

confidence: 99%

Untitled

2016

IJPSR

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ABSTRACT:A new, simple, accurate, linear, precise, efficient and reproducible Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method for the simultaneous determination of Ambroxol and Doxofylline in combined tablet dosage form. The chromatographic method was standardized using a Kromosil C18, 150mm × 4.6 mm, 3.5 (particle size), Thermo scientific from Germany with isocratic conditions, and mobile phase containing potassium dihydrogen orthophosphate buffer-pH 6.8 (0.01M KH 2 PO 4 ): acetonitrile (25: 75) at flow rate of 1ml/min using UV detection at 257 nm. The retention times of Ambroxol and Doxofylline were 5min and 2min, respectively. The method was linear over the concentration range for Ambroxol 0.6-36 g/mL and for Doxofylline 16-96 g/mL. The recovery of Ambroxol and Doxofylline was found to be in the range of 98.13-99.85% and 98.09-99.66%, respectively. The validation of method was carried out using ICH guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. From the comprehensive validation conducted, it was concluded that the method is stable and could be used throughout shelf life of the drug.

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“…It blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT 1 in the lungs and bronchial tubes by binding to it and is being used in the treatment of asthma 1,2 . The recommended dosage of MON is 10 mg per day.…”

Section: -[2-(1-hydroxy-1-methylethyl) Phenyl] Propyl -Sulfanylmethymentioning

confidence: 99%

Development and Validation of RP-HPLC Method for Estimation of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Preparations

2013

Chem Sci Trans

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Abstract:Objective of the present work was to develop a simple and precise HPLC method for montelukast sodium (MON) and fexofenadine hydrochloride (FEX). The combination is used as anti-asthmatic, anti-allergic and is available in tablet dosage form. HPLC separation was achieved with a hypersil ODS-C18 (5 µ, 250 mm x 4.6 mm, i.d.) as a stationary phase and methanol: acetonitrile: 1% trifluoroacetic acid (80:10:10 v/v/v) as eluent, at a flow rate of 1.0 mL/min, UV detection was performed at 210 nm. The retention time of montelukast sodium and fexofenadine hydrochloride were found to be 5.1 and 3.7 min respectively. Results of analysis were validated by recovery studies. Result of studies showed that the proposed RP-HPLC method is simple, rapid, accurate and precise which can be used for the routine determination of montelukast sodium and fexofenadine hydrochloride in bulk and its pharmaceutical dosage form.

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Development and validation of a RP-HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form

Cited by 42 publications

References 14 publications

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

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

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Development and Validation of RP-HPLC Method for Estimation of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Preparations

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