Validated green high‐performance liquid chromatographic methods for the determination of coformulated pharmaceuticals: A comparison with reported conventional methods

Abstract

The introduction of sustainable development concepts to analytical laboratories has recently gained interest, however, most conventional high-performance liquid chromatography methods do not consider either the effect of the used chemicals or the amount of produced waste on the environment. The aim of this work was to prove that conventional methods can be replaced by greener ones with the same analytical parameters. The suggested methods were designed so that they neither use nor produce harmful chemicals and produce minimum waste to be used in routine analysis without harming the environment. This was achieved by using green mobile phases and short run times. Four mixtures were chosen as models for this study; clidinium bromide/chlordiazepoxide hydrochloride, phenobarbitone/pipenzolate bromide, mebeverine hydrochloride/sulpiride, and chlorphenoxamine hydrochloride/caffeine/8-chlorotheophylline either in their bulk powder or in their dosage forms. The methods were validated with respect to linearity, precision, accuracy, system suitability, and robustness. The developed methods were compared to the reported conventional high-performance liquid chromatography methods regarding their greenness profile. The suggested methods were found to be greener and more time- and solvent-saving than the reported ones; hence they can be used for routine analysis of the studied mixtures without harming the environment.

Stability‐indicating chromatographic and chemometric methods for environmentally benign determination of canagliflozin and its major degradation product; A comparative study and greenness assessment

“…Degradation product structure was elucidated using mass and IR analyses (Emam, ). The development of greener methods requires green aspects to be considered at the method development stage (Elzanfaly, Hegazy, Saad, Salem, & Abd El Fattah, ). However, as per the literature survey, all of the reported methods were not concerned with the importance of applying green methods and no protocol for applying green chemistry was followed.…”

Development and validation of HPTLC and green HPLC methods for determination of furosemide, spironolactone and canrenone, in pure forms, tablets and spiked human plasma

“…High-performance liquid chromatography is probably the most multilateral and potent tool for quantifying and purifying numerous individual components in complex mixtures (Elzanfaly, Hegazy, Saad, Salem, & Abd El Fattah, 2015). Regarding the greenness of the developed method, reversed-phase HPLC is preferable to normal-phase HPLC.…”

“…Each quadrant is considered either green or blank, relying on the method fit to that specific criterion. Accordingly, the analyst is able to easily assess and compare the greenness of the analytical methods through examination of the overall profile (Elzanfaly et al, 2015;Keith et al, 2007). In the proposed RP-HPLC method, water and ethanol are defined as neither PBT nor hazardous by the US Environmental Protection Agency's Toxic Release Inventory (Elzanfaly et al, 2015;Keith et al, 2007), while methanol and formic acid, which are not recommended environmentally, were used in the reported method (Sora et al, 2010).…”

“…The pH of the mobile phase is 3.5, i.e. not corrosive (Elzanfaly et al, 2015). Chromatographic separation was achieved on a short column (100 mm) with smaller particle size (3.5 μm) than the reported HPLC that used longer columns of 25cm (Sora et al, 2010).…”

Greening Reversed-Phase Liquid Chromatography Methods Using Alternative Solvents for Pharmaceutical Analysis

“…Green RP-HPLC methods using ethanol-based mobile phases have been widely reported for the analysis of drugs in pharmaceutical formulations [ 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 ], as well as in biological samples [ 55 , 56 ] ( Table 1 ). For example, a HPLC/diode-array detector (DAD) method using EtOH as the organic solvent in the mobile phase and an octadecyl-grafted silica column, was developed and validated by our team for the analysis of statins (i.e., pravastatin, fluvastatin, and atorvastatin in high concentrated EtOH/water solutions) [ 42 ].…”