Creation and Verification of a Stability Indicating Assay Method for Identifying a Model Drug in Pharmaceutical Dosage Form and Bulk Using HPLC

• B Krishnamurti

  English

  Author

• KS Rani

  English

  Author

Developing an RP-HPLC method for determining a model drug in pharmaceutical dose form and bulk
was the goal of the current effort. A Hypersil BDS C18 column (250 x 4.60 x 5μm) with a mobile phase
consisting of 7.5 Phosphate buffer: Acetonitrile in a ratio of 300:700 was used to optimize the Agilent
Chromatographic system. Using UV detection at 215 nm, the flow rate was set to 2.0 ml/min. The retention
durations for DCL elution were 9.30±0.3 min. For DCL, Beer's Lambert's Law was followed within the
concentration ranges of 27.97–51.94 mcg/ml. The method's applicability for quantitative drug analysis in
a liquid dosage form is confirmed by the high recovery and low coefficients of variation. The method's
sensitivity and significance for analyzing DCL in pharmaceutical dosage form and pure form without
excipient interference are demonstrated by statistical analysis. According to ICH criteria, the approach
was validated.

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