Open AccessUPLC Method Development and Validation for the Determination of Chlophedianol Hydrochloride in Syrup Dosage Form
Author(s) -
Anas Rasheed,
Osman Hassan Ahmed
Publication year - 2017
Publication title -
international journal of applied pharmaceutical sciences and research
Language(s) - English
Resource type - Journals
ISSN - 2455-8095
DOI - 10.21477/ijapsr.v2i2.7775
Subject(s) - chromatography , dosage form , detection limit , chemistry , high performance liquid chromatography , acetonitrile , retention time , linear regression , calibration curve , methanol , linearity , analytical chemistry (journal) , mathematics , statistics , physics , organic chemistry , quantum mechanics
A specific, precise, accurate ultra pressure liquid chromatography (UPLC) method is developed for estimation of chlophedianol hydrochloride in bulk drug and syrup dosage form. The method employed with Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) in a gradient mode, with mobile phase of methanol and acetonitrile in the ratio of 65:35 %v/v. The flow rate was 0.1 ml/min and effluent was monitored at 254 nm. Retention time was found to be 1.130±0.005 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ)in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 20-100 μg/ml respectively. The LOD and LOQ values were found to be 2.094(μg/ml)and 6.3466(μg/ml)respectively. No chromatographic interference from syrup excipients and degradants were found. The proposed method was successfully used for estimation of chlophedianol hydrochloride in syrup dosage form.