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DOI Prefix 10.20431 |
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Method Validation for Assay of Loperamide Hydrochloride by HPLC in Loperamide Hydrochloride Tablets
Homayun Kabir1*,Ratan Kumar Paul1,Md.Saifur Rahaman2,Md.Faruak Ahmad1,Debu Kumar Bhattacharjya3,Md.Samsur Rahaman4
2.Atomic Energy Research Establishment, Bangladesh Atomic Energy Commission, Bangladesh
3.Department of Biochemistry, Sher-e-Bangla Agricultural University, Dhaka, Bangladesh
4.Department of Applied Chemistry, Islamic University, Kushtia-Jhenaidah -7003, Bangladesh
Citation :Homayun Kabir,et.al, Method Validation for Assay of Loperamide Hydrochloride by HPLC in Loperamide Hydrochloride Tablets International Journal of Advanced Research in Chemical Science 2017,4(4) : 11-27
A simple, selective, linear, specific, precise and accurate High Performance Liquid Chromatography (HPLC) method was developed and validated for rapid assay of Loperamide Hydrochloride in finished product. Isocratic elution at a flow rate of 1.5 ml/min was employed on an Inertsil-ODS 3V, C18, 100*4.6 mm, 5μcolumn. The UV detection wavelength was 224 nm. The mobile phase consisted of acetonitrile: buffer: 1M NaOH = 390: 610: 0.5.The method was validated in terms of linearity, specificity, accuracy, precision and robustness study. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The method was successfully applied to the analysis of pharmaceutical formulation containing Loperamide Hydrochloride with excellent recovery.