Sunday , 19 May 2024

RP-HPLC Method Development and Validation for Estimation of Metadoxine in API and Pharmaceutical Dosage form

R. Chaitanya*, D. Vijaya Durga, Dr. K. Padmalatha
Department of Pharmaceutical Analysis, Vijaya Institute of Pharmaceutical Sciences for women, Enikepadu, Andhra Pradesh.

A rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method has been developed and validated for Metadoxine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a cap cell pack C18 (250 x 4.6mm, 5µm) column using a mixture of ACN: Water (65:35% v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 305nm. The Retention time of the Metadoxine was 3.155±0.02min respectively. The method produce linear responses in the concentration range of 10-50µg/ml of Metadoxine. The precision of the method was demonstrated with %RSD values of below 2% while the % recovery was found in between 98102%. There is no interference of any compounds present in pharmaceutical dosage form was observed. According to the validation results the proposed method was found to be rapid, simple, specific, accurate, precise and robust. The method is useful in the quality control of bulk and pharmaceutical formulations.
Keywords: Metadoxine, RP-HPLC, validation.

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