Saturday , 8 May 2021

Analytical Method Development and Validation for the Determination of Griseofulvin in bulk and Its Solid Oral Dosage form using RP-HPLC

U. Srinivasulu*1, N. Devanna2, M.Suneetha3, B. Siva Sai Kiran3, S. Muneer3
1Associate Professor of Chemistry, SBSYM Degree College, Kurnool-518004, A.P., India
2Professor and Director, Department of Chemistry, JNTUA-Oil Technological and Pharmaceutical Research Institute, Ananthapuramu-515002, A.P., India.
3Department of Pharmaceutical Sciences, JNTUA-Oil Technological and Pharmaceutical Research Institute, Ananthapuramu-515002, A.P., India

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A simple, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) coupled with a SPD detector method was developed for the quantitative determination of Griseofulvin (GSF) in bulk and its pharmaceutical dosage form. The method is applicable to the quantification of drug product. Chromatographic separation was achieved on a Phenomenex Luna reversed phase C18 (250 mm x 4.6 mm, 5 μm) column. The optimized isocratic mobile phase consists of a mixture of methanol: water (0.1% Orthophosphoric acid) in the ratio of 55:45 % v/v. The eluted compounds were monitored at 295 nm for GSF assay, the flow rate was 1 mL/min, and the column oven temperature was maintained at ambient temperature. The developed method separated GSF from its excipients within 5.0 min. The developed method was validated as per ICH guidelines. The method was validated for specificity, linearity, precision, accuracy, robustness and system suitability. The method was linear in the drug concentration range of 10-60 μg/mL. The precision (% RSD) of six samples was found within 2. The mean recoveries were between 99.75%. The proposed method can be used successfully for routine analysis of the drug in bulk and combined pharmaceutical dosage forms.

Keywords: Methanol, Phenomenex Luna, Griseofulvin and Chromatographic separation

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