Development and validation of High-Performance Liquid Chromatographic Technique to Estimate Pure Form of Loperamide Hydrochloride

[摘要] A simple and reliable reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated to evaluate dissolution of Loperamide hydrochloride pharmaceutical dosage form. The method was developed on NovapakC18, (150 mm x 4.6 mm, 5 μm) with acetonitrile (55:45% v/v) as the mobile phase. The effluent was monitored by UV visible detector at 226 nm, at 1.5 ml/min flow rate and 5µ injection volume. The calibration curve was linear against a concentration range of 0.2 – 4μg/ml. For system and method precision, % RSD values were found to be 0.16 and 1.03, respectively. Recovery was found to be in the range of 98% to 101%. The RP-HPLC method developed has considerable importance and significant industrial applicability for QC (quality control) and analysis of loperamide hydrochloride tablet dosage form. This method can be applied in the routine analysis of pharmaceutical formulations of this drug. A simple and reliable reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated to evaluate dissolution of Loperamide hydrochloride pharmaceutical dosage form. The method was developed on NovapakC18, (150 mm x 4.6 mm, 5 μm) with acetonitrile (55:45% v/v) as the mobile phase. The effluent was monitored by UV visible detector at 226 nm, at 1.5 ml/min flow rate and 5µ injection volume. The calibration curve was linear against a concentration range of 0.2 – 4μg/ml. For system and method precision, % RSD values were found to be 0.16 and 1.03, respectively. Recovery was found to be in the range of 98% to 101%. The RP-HPLC method developed has considerable importance and significant industrial applicability for QC (quality control) and analysis of loperamide hydrochloride tablet dosage form. This method can be applied in the routine analysis of pharmaceutical formulations of this drug.

[学科分类] 药学、药理学、毒理学（综合）

[关键词] Loperamide hydrochloride;HPLC;pharmaceutical dosage form;validation