Keywords
RP-HPLC
ICH
LOD
LOQ
How to Cite
Abstract
A simple precise, accurate RP-HPLC method has been developed and validated for analysis of Zolmitriptan (ZLM). The separation and quantization were achieved on a 250 mm reversed phase column with a hydrophilic linkage between silica particles and hydrophobic alkyl chains. The mobile phase was constituted (flow rate 0.8 ml min-1) of eluant A (CH3OH) and eluant B (aqueous tetra butyl ammonium hydrogen sulphate) (pH 3.4; 10 mM) using isocratic elution with UV detection at 224 nm. The method showed good linearity for ZMT in the 1–100 μg mL-1 range with regression equation 15576x ± 99401 and correlation coefficient 0.999 respectively. The limit of quantitation (LOQ) and limit of detection (LOD) were found to be 0.8134 and 0.2687 μg mL-1 respectively. Finally the applicability of the method was validated according to ICH guidelines and can be applicable for the analysis of commercial dosage forms.
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International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical for Human Use: Validation of Analytical procedures, Text and methodology - Q2 (R1), 2005.
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