Unique green chromatography method for the determination of serotonin receptor antagonist (Ondansetron hydrochloride) related substances in a liquid formulation, robustness by quality by design‐based design of experiments approach

Abstract

Serotonin receptor antagonist drug Ondansetron hydrochloride injectable formulation containing all related substances was identified and quantified by a single, simple, sensitive, eco-friendly, and green high-performance liquid chromatography method. The disseverment of all impurities was achieved with the Discovery Cyano (250 × 4.6) mm, 5 μm column. The gradient program was composed of pH 5.7 phosphate buffer as mobile phase A and acetonitrile as mobile phase B. The flow rate, column compartment temperature, and detection wavelengths were 0.9 mL/min, 30 • C, and 216 nm, respectively. The method was validated as per current regulatory guidelines. The obtained %relative standard deviation for the precision results was between 0.55 and 2.72% for all impurities. The correlation coefficient values from the linearity experiment for impurities and analyte were more than 0.995. The accuracy results were obtained between 88.4 and 113.0% for all impurities. Both sample and standard solutions showed 24 h stability at benchtop and refrigerator conditions. All impurities and analytes met the specificity and mass balance for all forced degradation conditions. Qualityby-design-based design of experiments was utilized to establish the method's robustness. Method greenness was assessed by using the current advanced tool green analytical procedure index, National Environmental Methods Index, and analytical eco-scale. K E Y W O R D Sanalytical eco-scale, design of experiments, green analytical procedure index, ondansetron hydrochloride, quality by design Article Related Abbreviations: ANOVA, analysis of variance; DoE, design of experiments; GAPI, Green Analytical Procedure Index; NEM, National Environmental Methods Index; OND, Ondansetron hydrochloride

Development and validation of novel RP‐HPLC method for midostaurin determination using analytical quality by design approach from regulatory perspective and determination of major degradation compounds of midostaurin using LC–MS

“…The specificity of the developed LC method for MTN was evaluated in the presence of its three impurities. Specificity solutions were prepared and injected into the PDA detector to demonstrate analyte peak homogeneity (Dongala et al, 2020;Ettaboina et al, 2022;Konduru et al, 2020;Kowtharapu et al, 2022aKowtharapu et al, , 2022b. Stress H 2 O 2 at 80 C for 48 h) to evaluate the ability of the proposed method to separate MTN from its degradation products.…”

Green Chromatographic Method for Determination of Active Pharmaceutical Ingredient, Preservative, and Antioxidant in an Injectable Formulation: Robustness by Design Expert

“…These three green metrics were utilized to confirm the method’s greenness. 29 − 34 The modern tool Analytical Greenness (AGREE) is also used to assess greenness. The approach was devised by the Gdańsk University of Technology, Poland, and expresses the greenness of the procedure based on 12 green chemistry principles.…”

“…Analytical eco-scale is another green chemistry metric that evaluates the method by calculating the penalty points and expresses the method’s eco-friendliness. These three green metrics were utilized to confirm the method’s greenness. − The modern tool Analytical Greenness (AGREE) is also used to assess greenness. The approach was devised by the Gdańsk University of Technology, Poland, and expresses the greenness of the procedure based on 12 green chemistry principles …”

Unique liquid chromatography technique for the determination of mirabegron in the presence of polymers; robustness by Design Expert in the light of Quality by Design

“…An experimental design constructed according to Quality by Design (QbD) can identify the individual effects as well as interactions of the critical method variables, such as the organic ratio, the pH of the buffer or mobile phase, the flow rate, the column oven temperature and the gradient composition (Konduru et al, 2020; Konduru et al, 2022; Kowtharapu, Katari, Ch, et al, 2022; Kowtharapu, Katari, Sandoval, et al, 2022). The current method robustness was studied utilizing the QbD‐based Design of Experiments with Design Expert software.…”