AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities
Abstract Preserving the environment, reducing the amount of waste resulting from chemical trials, and reducing the amount of energy consumed have currently become a pivotal global trend. An analytical quality by design (AQbD) based eco-friendly TLC-densitometric method was implemented for quantifyin...
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | BMC Chemistry |
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| Online Access: | https://doi.org/10.1186/s13065-024-01125-2 |
| _version_ | 1797340338840403968 |
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| author | Hend M. Nagieb Nada S. Abdelwahab Maha M. Abdelrahman Hala E. Zaazaa Nermine S. Ghoniem |
| author_facet | Hend M. Nagieb Nada S. Abdelwahab Maha M. Abdelrahman Hala E. Zaazaa Nermine S. Ghoniem |
| author_sort | Hend M. Nagieb |
| collection | DOAJ |
| description | Abstract Preserving the environment, reducing the amount of waste resulting from chemical trials, and reducing the amount of energy consumed have currently become a pivotal global trend. An analytical quality by design (AQbD) based eco-friendly TLC-densitometric method was implemented for quantifying two antihypertensive agents, captopril (CPL) and hydrochlorothiazide (HCZ), along with their impurities; captopril disulphide (CDS), chlorothiazide (CTZ) and salamide (SMD). The analytical target profile (ATP) was first identified, followed by selecting the critical analytical attributes (CAAs), such as retardation factors and resolution between the separated peaks. Critical method parameters (CMPs) that may have a crucial influence on CAAs were identified and emanated through the quality risk assessment phase. A literature survey-based preliminary studies were performed, followed by optimization of the selected CMPs through a custom experimental design to attain the highest resolution with optimum retardation factors. Moreover, method robustness was also tested by testing the design space. Complete separation of the drugs and their impurities was achieved using ethyl acetate: glacial acetic acid (6: 0.6, v/v) as a developing system applied to a 12 cm length TLC plate at room temperature with UV scanning at 215 nm. Calibration graphs were found to be linear in the ranges of (0.70–6.00), (0.10–2.00), (0.20–1.00), (0.07–1.50) and (0.05–1.00) µg/band corresponding to CPL, HCZ, CDS, CTZ, and SMD, respectively. Four different green metric tools were used to evaluate the greenness profile of the proposed method, and results showed that it is greener than the reported HPLC method. Method whiteness assessment was also conducted. Moreover, the method performance was evaluated following the ICH guidelines, and the outcomes fell within the acceptable limits. The developed method could be approved for routine assay of the cited components in their pharmaceutical formulations and bulk powder without interference from the reported impurities. The issue of concern is saving money, especially in developing countries. |
| first_indexed | 2024-03-08T10:01:41Z |
| format | Article |
| id | doaj.art-43ff3015def44b73a6b3b2d8a4692ef2 |
| institution | Directory Open Access Journal |
| issn | 2661-801X |
| language | English |
| last_indexed | 2024-03-08T10:01:41Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Chemistry |
| spelling | doaj.art-43ff3015def44b73a6b3b2d8a4692ef22024-01-29T10:55:08ZengBMCBMC Chemistry2661-801X2024-01-0118111910.1186/s13065-024-01125-2AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impuritiesHend M. Nagieb0Nada S. Abdelwahab1Maha M. Abdelrahman2Hala E. Zaazaa3Nermine S. Ghoniem4Pharmaceutical Chemistry, Faculty of Pharmacy, Nahda University [NUB]Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef UniversityPharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef UniversityAnalytical Chemistry, Faculty of Pharmacy, Cairo UniversityAnalytical Chemistry, Faculty of Pharmacy, Cairo UniversityAbstract Preserving the environment, reducing the amount of waste resulting from chemical trials, and reducing the amount of energy consumed have currently become a pivotal global trend. An analytical quality by design (AQbD) based eco-friendly TLC-densitometric method was implemented for quantifying two antihypertensive agents, captopril (CPL) and hydrochlorothiazide (HCZ), along with their impurities; captopril disulphide (CDS), chlorothiazide (CTZ) and salamide (SMD). The analytical target profile (ATP) was first identified, followed by selecting the critical analytical attributes (CAAs), such as retardation factors and resolution between the separated peaks. Critical method parameters (CMPs) that may have a crucial influence on CAAs were identified and emanated through the quality risk assessment phase. A literature survey-based preliminary studies were performed, followed by optimization of the selected CMPs through a custom experimental design to attain the highest resolution with optimum retardation factors. Moreover, method robustness was also tested by testing the design space. Complete separation of the drugs and their impurities was achieved using ethyl acetate: glacial acetic acid (6: 0.6, v/v) as a developing system applied to a 12 cm length TLC plate at room temperature with UV scanning at 215 nm. Calibration graphs were found to be linear in the ranges of (0.70–6.00), (0.10–2.00), (0.20–1.00), (0.07–1.50) and (0.05–1.00) µg/band corresponding to CPL, HCZ, CDS, CTZ, and SMD, respectively. Four different green metric tools were used to evaluate the greenness profile of the proposed method, and results showed that it is greener than the reported HPLC method. Method whiteness assessment was also conducted. Moreover, the method performance was evaluated following the ICH guidelines, and the outcomes fell within the acceptable limits. The developed method could be approved for routine assay of the cited components in their pharmaceutical formulations and bulk powder without interference from the reported impurities. The issue of concern is saving money, especially in developing countries.https://doi.org/10.1186/s13065-024-01125-2HydrochlorothiazideCaptoprilTLC-densitometryImpuritiesAQbDGAC principles |
| spellingShingle | Hend M. Nagieb Nada S. Abdelwahab Maha M. Abdelrahman Hala E. Zaazaa Nermine S. Ghoniem AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities BMC Chemistry Hydrochlorothiazide Captopril TLC-densitometry Impurities AQbD GAC principles |
| title | AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities |
| title_full | AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities |
| title_fullStr | AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities |
| title_full_unstemmed | AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities |
| title_short | AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities |
| title_sort | aqbd tlc densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities |
| topic | Hydrochlorothiazide Captopril TLC-densitometry Impurities AQbD GAC principles |
| url | https://doi.org/10.1186/s13065-024-01125-2 |
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