title: HPTLC-Densitometric Determination of Cetirizine and Montelukast Analysis in Combined Tablet Dosage Forms.
abstract: A simple, accurate and rapid high performance thin layer chromatography (HPTLC)- densitometric method was developed for separation and determination of cetirizine (CET) as a long acting antihistamine and montelukast (MON) as an antileukotriene in pharmaceutical dosage forms. The compounds were separated on silica gel 60 F254 HPTLC plates using a mixture of ethyl acetate : methanol : ammonia solution (25%) (14 : 3 : 2 v/v/v) as mobile phase. The plates were developed vertically up to a distance of 80 mm. Compact spots of both cetirizine (Rf = 0.30 ± 0.01) and montelukast (Rf = 0.52 ± 0.02) were obtained. UV detection was performed at 230 nm. Quantitative analysis was performed by absorbance densitometry using peak area. The method was validated in terms of linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves were linear in the range of 40-2000 ng spot(-1) for cetirizine and 120-1000 ng spot(-1) for montelukast. For MON, recovery varied in range of 99.20-100.88% with RSD ranging from 1.02 to 1.90% and for CET, recovery varied in range of 98.13-100.05% with RSD ranging from 1.57 to 1.85%. The LODs were found to be 3.94 and 2.08 ng spot(-1) for CET and MON, respectively. It was observed that the proposed HPTLC method could be used for efficient analysis and monitoring of the CET and MON in combined tablet dosage forms, more convenient with better precision and accuracy than HPLC method.
authors.affiliation: Quality Control laboratory, Darou Pakhsh Mfg. Co., Tehran, Iran.
authors.forename: Saeed
authors.initials: S
authors.lastname: Haghighi
authors.forename: Mahmoud Reza
authors.initials: MR
authors.lastname: Shapouri
authors.forename: Mitra
authors.initials: M
authors.lastname: Amoli-Diva
authors.forename: Kamyar
authors.initials: K
authors.lastname: Pourghazi
authors.forename: Hossein
authors.initials: H
authors.lastname: Afruzi
keywords: Cetirizine; Densitometry; HPTLC; Montelukast; Quantitative Analysis