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Asian Journal of Pharmaceutical Analysis
Year : 2019, Volume : 9, Issue : 3
First page : ( 107) Last page : ( 112)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2019.00020.6

Analytical Method Development and Validation for Simultaneous Estimation of some drugs in Pharmaceutical Dosage Form

Gulhane C. A.1,*, Khadabadi S. S.1, Atram S. C.2

1Government College of Pharmacy, Amravati, Maharashtra, India

2Vidyabharati College of Pharmacy, Amravati, Maharashtra, India

*Corresponding Author E-mail: Chaitanyagulhane60@gmail.com

Online published on 31 December, 2019.

Abstract

A new reversed-phase high performance liquid chromatography method was developed forsimultaneous determination of Fexofenadine hydrochloride (FEXO) and Montelukast sodium (MONTE) in combined tablet formulation. Efficient separation was achieved on C18 Grace Column (4.6×250 mm, 5 um) as stationary phase comprising of Methanol and Water (70: 30, v/v) as mobile phase by using 0.05% Orthophosphoric acid of which pH Adjusted to 2.5 with flow rate 1ml/min. Detection was carried out in UV 730 D PDA detector at 241.0nm. The retention time 6.0167 min and 8.500 min approximately of FEXO and MONTE respectively. The linearity of the FEXO and MONTE was found over the range of 60μg/mL to 300μg/mL and 5μg/mL to 25μg/mL. The developed method was accurate, precise, economic, fast, and selective. The method gives good resolution for drugs. By using above method, FEXO & MONTE were separated with good peaks, minimum tailing, good retention time, resolution time between peak were sufficient. Hence this method was suitable and finalized.

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Keywords

Fexofenadine hydrochloride, Montelukast Sodium, HPLC, Validation, Simultaneous estimation, ICH guidelines.

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