Validation of an HPLC Analytical Method for Determination of Pancuronium Bromide in Pharmaceutical Injections

Abstract

Pancuronium bromide is used with general anesthesia in surgery for muscle relaxation and as an aid to intubation. A high performance liquid chromatographic method was fully validated for the quantitative determination of pancuronium bromide in pharmaceutical injectable solutions. The analytical method was performed on an amino column (Luna® 150 mm × 4.6 mm, 5 µm). The mobile phase was composed of acetonitrile:water containing 50 mmol L⁻¹ of 1-octane sulfonic acid sodium salt (20:80 v/v) with a flow rate of 1.0 mL min⁻¹ and ultraviolet (UV) detection at 210 nm. The proposed analytical method was compared with that described in the British Pharmacopoeia.

Keywords:

• High performance liquid chromatography
• pancuronium bromide
• validation of analytical method

The authors wish to thank Cristália Produtos Quıéicos Farmacêuticos Ltda. and Organon do Brasil Indústria e Comeércio Ltda. by donation of standard and samples. This research was supported by CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico 142664/2005-7).

Notes

*Amount in mg mL⁻¹.

* Tabulated Snedecor F-value with P = 95%; F _8/8  = 4.43.

** Tabulated Studen[tacute]s t-value with P = 95% and 16 degrees of freedom; t = 2.12.