Determination of Gefitinib Using Routine and Greener Stability-Indicating HPTLC Methods: A Comparative Evaluation of Validation Parameters

Abstract

“High-performance thin-layer chromatography (HPTLC)” methods for gefitinib (GFT) estimation are scarce in the literature. In addition, greener analytical techniques for GFT estimation are also lacking in the literature. Accordingly, an attempt was undertaken to invent and validate a sensitive and greener normal-phase HPTLC method for GFT analysis in commercial tablets in comparison to the routine normal-phase HPTLC method. The greenness index for both methods was assessed using “Analytical GREENness (AGREE)” methodology. GFT detection was carried out using both methods at 332.0 nm. In the 30–700 ng/band and 20–1400 ng/band ranges, the routine and greener HPTLC assays were linear for GFT estimation. The greener HPTLC method was highly sensitive, more accurate, more precise, and more robust than the routine HPTLC assay for GFT estimation. Both methods were able to detect GFT in the presence of its degradation products, suggesting the stability-indicating property of both methods. The assay of GFT in commercial tablets was 92.45% and 99.74% using the routine and greener HPTLC assays, respectively. The AGREE index for routine and greener analytical assays was predicted to be 0.44 and 0.77, respectively, indicating the excellent greenness index of the greener HPTLC assay over the routine HPTLC assay. The greener HPTLC assay is considered superior to the routine HPTLC assay based on these results.

Comparing the Greenness and Validation Metrics of Traditional and Eco-Friendly Stability-Indicating HPTLC Methods for Ertugliflozin Determination

“…Chamber saturation conditions were used in the development of the TLC plates for both techniques. As the traditional mobile phases for the ERZ analysis by the NP procedure, a variety of CHCl 3 /MeOH combinations between 45 and 95% CHCl 3 were examined Table lists the combinations of traditional mobile phases and other chromatographic responses.…”

“…As the traditional mobile phases for the ERZ analysis by the NP procedure, a variety of CHCl 3 /MeOH combinations between 45 and 95% CHCl 3 were examined. 46 Table 1 lists the combinations of traditional mobile phases and other chromatographic responses. The traditional mobile phase CHCl 3 /MeOH (85:15 v/v) produced a well-eluted and sharp chromatographic signal for ERZ at R f = 0.29 ± 0.01 ( Figure 1 A), according to the results.…”

“…HPTLC analytical procedures present numerous benefits such as low solvent usage/waste, nondestructive mode of detection, ease of use, minimal pretreatment, efficiency, simultaneous detection of multiple samples, nontoxic, and greenness features over conventional liquid chromatography methods (HPLC, LC-MS, and UPLC methods) for the analysis of pharmaceutical compounds. 27,28 Currently, HPTLC approaches have been utilized for the green analysis of various pharmaceutical compounds and medications. 27−30 One of the 12 principles of "green analytical chemistry (GAC)" is the use of ecologically acceptable solvent replacements to lessen the harmful effects of toxic or hazardous eluents on the ecosystem.…”

Eco-Friendly High-Performance Thin-Layer Chromatography Method for the Determination of Tenoxicam in Commercial Formulations

“…46 In comparison to traditional liquid chromatographic techniques, the HPTLC method has a number of benefits, including ease of use, little pretreatment, sensitivity, efficiency, simultaneous analysis of many samples, a nondestructive mode of detection, low solvent consumption, short analysis time, and low cost. 38,39 Based on these details and findings, the current approach aims to design and evaluate an environmentally friendly reversed-phase HPTLC strategy for the measurement of TNX in procured tablets and capsules. Enhancing the greenness index of analytical procedures with good sensitivity, accuracy, precision, robustness, and environmental friendliness is a good approach to reducing the toxic effects of conventional liquid chromatographic methods.…”