Quantification of Pomalidomide Using Conventional and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of Validation Parameters

Abstract

High-performance thin-layer chromatographic (HPTLC) assays for pomalidomide (PMD) measurement are lacking in the published database. Furthermore, eco-friendly stability-indicating analytical assays for PMD measurement are also lacking in the published database. In order to detect PMD in commercial products more accurately and sustainably than the conventional normal-phase HPTLC (NP-HPTLC) assay, an effort was made to design and verify a sensitive and eco-friendly reversed-phase HPTLC (RP-HPTLC) assay. The silica gel 60 NP-18F254S and 60 RP-18F254S plates were used as the stationary phases for NP-HPTLC and RP-HPTLC methods, respectively. The solvent system for NP-HPTLC was chloroform–methanol (90:10 v/v). However, the solvent system for RP-HPTLC was ethanol–water (75:25 v/v). The greenness scores for both assays were measured by AGREE approach. PMD measurement was performed for both assays at 372 nm. In the 50–600 and 20–1000 ng/band ranges, the NP-HPTLC and RP-HPTLC methods were linear for PMD measurement. The RP-HPTLC assay was superior to the NP-HPTLC method for measuring PMD in terms of sensitivity, accuracy, precision, and robustness. The ability of both methods to identify PMD in the presence of its degradation products suggests that both methods have stability-indicating features. When employing the NP-HPTLC and RP-HPTLC assays, respectively, the assay for PMD in commercial capsules was 88.68 and 98.83%. The AGREE scores for NP-HPTLC and RP-HPTLC assays were calculated to be 0.44 and 0.82, respectively, suggesting an outstanding greenness characteristic of the RP-HPTLC method than the NP-HPTLC method. The RP-HPTLC method was found to be superior to the NP-HPTLC method based on these findings. Therefore, the RP-HPTLC method could be successfully applied for the determination of PMD in pharmaceutical products.

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

“…To the best of our knowledge, no reports of ERZ measurement in commercial products have been made using traditional or eco-friendly HPTLC techniques. 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. , Currently, HPTLC approaches have been utilized for the green analysis of various pharmaceutical compounds and medications. − 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 . A literature search revealed that the use of greener solvents has grown dramatically during the last few decades. − Numerous qualitative and quantitative techniques for assessing the greenness profiles of analytical processes have been described in the literature.…”

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

“…Utilizing alternative environmentally acceptable eluents to reduce the harmful impacts of toxic solvents on the ecosystem is one of the 12 principles of green analytical chemistry (GAC), which is a method of chemical analysis . A literature search found an exponential rise in the usage of environmentally friendly solvents over the past few decades. − The literature has described a number of approaches to assess the analytical methodologies’ greenness profiles. − To measure greenness profiles, only the Analytical GREEnness (AGREE) technique applies all 12 GAC principles. , As a result, the AGREE approach was used to calculate the greenness profiles of the current method . 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. , 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. As a result, the proposed method was used in this study. − Using the International Council for Harmonization (ICH)-Q2-R1 guidelines, the proposed approach for TNX analysis was validated…”

“… 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.…”

“…As a result, the proposed method was used in this study. 37 − 39 Using the International Council for Harmonization (ICH)-Q2-R1 guidelines, the proposed approach for TNX analysis was validated. 47…”