Rapidly, sensitive quantitative assessment of thiopental via forced stability indicating validated RP-HPLC method and its in-use stability activities

Abstract

Thiopental sodium (Tho) is an intravenous anesthetic. The current study aimed to find a rapid RP-HPLC method of Tho analysis with high linearity, repeatability, sensitivity, selectivity, and inexpensive. In our developed method, there is no need to use special chemical reagents, a high percentage of organic solvent, a high flow rate, or a further guard column. The chromatographic system consists of an ODS column (150 mm × 4.6 mm × 5 μm). The mobile phase was prepared by mixing KH2PO4 solution: methanol (40:60) with a flow rate of 1.2 mL/min at a detection wavelength of 230 nm, at room temperature using an injection volume of 10 μL. The method manifested a satisfied linearity regression R2 (0.9997) with a good repeatability precision range (0.16–0.47%) with LOD and LOQ; 14.4 μg/mL and 43.6 μg/mL respectively. Additionally, the method proved its efficiency via system suitability achievement in robustness and ruggedness, according to the validation guidelines. The shorter analysis time makes the method very valuable in quality control to quantify the commercial Tho in pharmaceutical preparations. This improved HPLC method has been successfully applied for Tho analysis for Thiopental UP Pharma 500 mg vials and Thiopental Eipico 1.0 g vials in our routine finished and stability studies testing laboratories. Additionally, the detection limit of Tho has been tested in our quality control lab to detect the smallest amount of traces that may be present after the cleaning process of the production machines for cephalosporins preparations. The method has shown positive results for Tho in low-level raw materials and pharmaceutical formulations.

Synthesis, Physicochemical Characterization using a Facile Validated HPLC Quantitation Analysis Method of 4-Chloro-phenylcarbamoyl-methyl Ciprofloxacin and Its Biological Investigations

“…Under the optimized parameters of the analytical method, these ranged from 2.1 to 2.4 and 3.4 to 3.9 minutes for Cpx and Cpx-Drv peaks, respectively, over all the parameter changes. Tables 2 and 3 Table 2; Table 3 show the high performance of the intended analysis method where the peak area RSD % ≤ 2.0%, USP tailing ≤ 2.0, theoretical plates ≥ 2000, and resolution ≥ 1.5 [23][24][25]. Hence, based on the obtained system suitability testing data, the method showed excellent validity through a wide range of retention times.…”

“…Both are two sides of the same coin and are used interchangeably. Accuracy describes the degree of closeness of the measured concentration value to the claimed theoretical concentration [23,24]. Accuracy was determined by weighing three different weights for each of Cpx and Cpx-Drv to produce theoretical concentrations at 35 µg/mL, 50 µg/mL, and 60 µg/mL.…”

Formulation and evaluation of azithromycin-loaded silver nanoparticles for the treatment of infected wounds

“…The free AZM concentration was measured according to the previously reported work ( Al-Hakkani, 2019c ; Al-Hakkani et al, 2022b ). All experiments were repeated three times, and the average values were determined following validation protocols to ensure high accuracy and precision ( Al-Hakkani, 2019a , Al-Hakkani, 2019b , Al-Hakkani, 2019c ; Al-Hakkani, 2023 ; Al-Hakkani et al, 2023a ; Al-Hakkani et al, 2023b ; Al-Hakkani et al, 2021b ; Al-Hakkani et al, 2022c ).…”

Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities

“…Ruggedness was submitted using designed and major observable changes including analyst-analyst, column-column, and day-day with maintaining all the analysis method parameters and conditions as it is without changes [ 37 ].…”