Rapid resolution liquid chromatography for monitoring the quality of stockpiled atropine preparations for injection

Abstract

We describe a rapid resolution liquid chromatography (RRLC) method for analyzing atropine sulfate, its degradation products (tropic acid, apoatropine, atropic acid) and other components (e.g. phenol, methylparaben) in injectable medicines that are used by the German armed forces in emergency situations. Chromatography is performed using an acetonitrile/phosphate buffer gradient (pH = 1.0) and an RP 18 column (50 x 4.6 mm, 1.8 µm) with the detection wavelength set at 220 nm. The concentration of the active ingredient (atropine sulfate) in the tested products ranges from about 1 mg•ml(-1) to 10 mg•ml(-1) . The concentrations of the detected degradation products range from 0.2% to 4.7% (tropic acid) in relation to the active pharmaceutical ingredient (API). Using shorter separation columns and smaller particle sizes of the stationary phase improved analysis time from 40 to 10 min and reduced the consumption of solvents by approximately 75%. Owing to the pressure conditions (< 200 bar), UHPLC (ultra high performance liquid chromatography) systems are not needed. Comparison of the atropine and tropic acid results obtained with the previously used HPLC (high performance liquid chromatography) method of the MAH (marketing authorization holder) show that there is no indication of a significant difference between the two methods.

Simultaneous determination of acepromazine and atropine residues in porks, livers, kidneys by Ultra‐High‐Performance Liquid Chromatography‐Tandem Mass Spectrometry

“…ATP could be determined by liquid chromatographic (LC) method with UV detection systems, [20,21] HPLC-UV, [22] HPLC-RP, [23] Rapid resolution liquid chromatography (RPLC), [24] or LC-MS. [25] Moreover, the accurate quantitative analysis method for determining these two chemicals in meat and meat products has not been officially issued. From the mentioned reality, the veterinary industry and authorities need to strengthen the control of slaughtering and inspection of veterinary hygiene of food, with the form of sanctions that can deter traders from committing illegal acts.…”

Development and Application of a Validated UHPLC Method for the Determination of Atropine and Its Major Impurities in Antidote Treatment Nerve Agent Auto-Injectors (ATNAA) Stored in the Strategic National Stockpiles

“…Due to the complex nature and variability of the impurities in this medical counter measure drug product, it was difficult to separate out all the related compounds and degradation impurities of atropine by available HPLC methodology [25]. However, when acceptable chromatographic resolution was achieved using HPLC, the analysis time for the determination of atropine and its impurities (apoatropine, tropic acid and atropic acid) was quite long (40 -70 minutes) (Figures 3-6).…”