Pharmacopoeial HPLC methodology improvement: A case study of piroxicam

Mikaelly P. Caet, Millena A. Monsores, Anna K.M.S. Machado, Thiago Barth, Maximiliano S. Sangoi, Vítor Todeschini


In the present study, a simple, stability-indicating and cost-effective reversed-phase high performance liquid chromatography (HPLC) method was developed and validated for the determination of piroxicam in commercial and masterful formulation capsules as an alternative to existing methods. The improved HPLC method was carried out on a C18 column (150 mm x 4.6 mm i.d., 5 μm), maintained at 30 °C. The mobile-phase consisted of a solution of triethylamine 0.3% pH 5.0 and acetonitrile (70:30; v/v), run at a flow rate of 1.0 mL/min and using photodiode array (PDA) detection at 248 nm. The chromatographic separation is obtained with retention time of 6.8 min, presenting adequate system suitability parameters for HPLC analysis. Validation parameters such as the specificity, linearity, matrix effect, precision, accuracy and robustness were evaluated in accordance with the ICH Q2(R1) and Brazil RDC 166/17 requirements, giving satisfactory results within the acceptable range. The proposed method was successfully validated and applied for piroxicam analysis, contributing to improve the quality control, and can be used as easy, accurate, low time-consuming alternative to pharmacopeial quantification methodology of drug.

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