Development and Validation of a Novel HPLC Method for the Determination of Ephedrine Hydrochloride in Nasal Ointment

Abstract

A simple, precise, and cost-effective reverse phase ion pair chromatographic (RP-IP-HPLC) method was developed and validated for the determination of Ephedrine Hydrochloride in a nasal ointment. A simple and fast extraction protocol was developed for the effective recovery of the analyte, and for this purpose, Bromhexine Hydrochloride was used as the internal standard. The mobile phase consisted of MeOH, Sodium Lauryl Sulfate (SLS) 49.8 mM, triethylamine (ET3N) in the ratio of 65:34.6:0.4%, respectively, with pH = 2.20. The detection of the compounds was carried out at 206 nm, and we used a PDA detector. A short run time was achieved with retention times of 6.3 min and 9.8 min for ephedrine hydrochloride and the internal standard, respectively. The proposed method was validated according to ICH guidelines. Linearity was confirmed in the range of 50–150 μg/mL. Recoveries results were within the range of 98–102% and precision < 2% for the analyte in spiked blank matrix. Robustness testing was conducted via a fractional factorial experimental design. The method was found to fulfill the required specifications for specificity and stability for both standard solutions and samples, as well and applied to the determination of ephedrine hydrochloride in nasal ointments produced by the Greek Military Pharmaceutical Laboratories.

Dissolution Assay of Bupropion/Naltrexone Hydrochloride Salts of Bilayer Composition Tablets Following the Development and Validation of a Novel HPLC Method

“…For the evaluation of the significant effects, the graphical approach was implemented [ 19 , 20 , 21 ]. The normal and half-normal plot graphs, along with Pareto charts, were utilized for this purpose.…”

Evaluation of stability of (1R,2 S)-(−)-2-methylamino-1-phenyl-1-propanol hydrochloride in plasma and urine samples-inoculated with Escherichia coli using high-performance liquid chromatography (HPLC)

“…HPLC is frequently employed as the preferred method for the analysis of ephedrines, a class of alkaloids commonly present in plants such as Ephedra sinica, owing to its high efficiency and sensitivity. There are many studies that have used this method to analyze biological samples to detect ephedrines such as (Abdel Salam et al 2013 ; ’Aksu Donmez et al 2018 ; Kallinteris et al 2022 ). There is a difference between the results of our current study and the study of Kallinteris et al ( 2022 ) (Kallinteris et al 2022 ), as we found that the retention time of ephedrines was 1.63 min, while Kallinteris and his colleagues stated that the retention time was 6.31 min.…”

“…There are many studies that have used this method to analyze biological samples to detect ephedrines such as (Abdel Salam et al 2013 ; ’Aksu Donmez et al 2018 ; Kallinteris et al 2022 ). There is a difference between the results of our current study and the study of Kallinteris et al ( 2022 ) (Kallinteris et al 2022 ), as we found that the retention time of ephedrines was 1.63 min, while Kallinteris and his colleagues stated that the retention time was 6.31 min. The observed discrepancy could potentially be attributed to variations in the chromatographic parameters employed throughout the experimental procedure, as well as disparities in the composition of the mobile phase.…”

Stability of (1R,2S)-(-)-Ephedrine hydrochloride in Candida albicans-inoculated urine and blood samples

“…HPLC, a chemical analysis method, has long been recognized as a reliable method for analyzing ephedrine in biological samples. For example, extensive research has established its suitability for this purpose such as ( Abdel Salam et al, 2013 , Aksu et al, 2018 , Kallinteris et al, 2022 ). The results of previous studies and our current study did not completely match due to differences in samples, extraction methods, mobile phase, and other differences.…”