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Validated, Stability-Indicating LC Method for Analysis of Pipenzolate Bromide and Its Hydrolysis Products

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Abstract

A liquid chromatographic method has been developed and validated for quantitative analysis of pipenzolate bromide (PP), its hydrolysis products, and phenobarbitone, sodium benzoate, and sodium saccharine. A 5-μm particle ODS column was used with acetonitrile–KH2PO4 (10 mm, pH 3.5) 40:60 (v/v), containing 5 mm heptanesulfonic acid sodium salt, as mobile phase. Quantitation was achieved by UV detection at 210 nm, on the basis of peak area. Forced degradation studies were performed on a bulk sample of PP using 0.1 M hydrochloric acid, 0.01 M sodium hydroxide, 0.33% hydrogen peroxide, heat (70 °C), and photolytic degradation. The proposed LC method was used to study the kinetics of acidic hydrolysis and pH-rate profiles of hydrolysis of PP in Britton–Robinson buffer solutions.

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Correspondence to Ghada M. Hadad.

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Hadad, G.M. Validated, Stability-Indicating LC Method for Analysis of Pipenzolate Bromide and Its Hydrolysis Products. Chroma 68, 207–212 (2008). https://doi.org/10.1365/s10337-008-0715-2

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