Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing
Abstract Background Cardiovascular disease medications such as aspirin (ASP), statins like atorvastatin (ATR), and blood pressure-lowering drugs including ACE inhibitors like ramipril (RAM) have been included in the World Health Organization (WHO) Essential Medicines List (EML) for many years. There...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-03-01
|
| Series: | BMC Chemistry |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13065-023-00929-y |
| _version_ | 1797865668940398592 |
|---|---|
| author | Nora A. Abdallah Amina M. El-Brashy Fawzia A. Ibrahim Mohamed I. El-Awady |
| author_facet | Nora A. Abdallah Amina M. El-Brashy Fawzia A. Ibrahim Mohamed I. El-Awady |
| author_sort | Nora A. Abdallah |
| collection | DOAJ |
| description | Abstract Background Cardiovascular disease medications such as aspirin (ASP), statins like atorvastatin (ATR), and blood pressure-lowering drugs including ACE inhibitors like ramipril (RAM) have been included in the World Health Organization (WHO) Essential Medicines List (EML) for many years. Therefore, there is a strong demand to develop a simple, rapid, and sensitive analytical method that can detect and quantitate the ternary mixture of these analytes in pharmaceutical preparations in a short run time. Lately, the analytical community focused on eliminating or reducing hazardous chemicals and solvents usage. Results A green, fast, selective, and cost-effective micellar HPLC method was established and validated for the concurrent determination of ternary combination of ASP, ATR, and RAM in the pure form and pharmaceutical preparations. Resolution of the three drugs was achieved by using a monolithic column and a micellar mobile phase consists of 0.3% triethylamine (TEA) in 90: 10 an aqueous solution of 0.12 M sodium dodecyl sulfate (SDS): n-propanol, (v/v). The pH was adjusted to 2.5 using orthophosphoric acid and a flow rate of 1.5 mL/min. was applied. To ensure method reproducibility, Valsartan (VAL) was utilized as an internal standard (IS). The UV detection of the studied drugs was performed at 210 nm. Good linearity for the three drugs was obtained over the concentration ranges of 1.0-200.0 mg/mL, 0.5-200.0 mg/mL, and 5.0-100.0 mg/mL with correlation coefficients of 0.9998,0.9999 and 0.9999 for ASP, ATR, and RAM respectively. The method sensitivity was revealed by the relatively small values of limits of detection (LOD) (0.19, 0.13 and 0.30 mg/mL) and limits of quantitation (LOQ) (0.63, 0.44 and 0.99 mg/mL) for ASP, ATR, and RAM, respectively. The retention times of ASP, ATR and RAM were 1.50, 2.3 and 4.3 min., respectively. Conclusions The suggested technique was employed for the analysis of the three drugs in their prepared tablets maintaining the recommended pharmaceutical ratio without any interference from excipients. The method was further extended to content uniformity testing of RAM. The results were validated according to international council for harmonisation (ICH) guidelines. |
| first_indexed | 2024-04-09T23:11:51Z |
| format | Article |
| id | doaj.art-53341df3e8be4d28999b3bc79fb1743b |
| institution | Directory Open Access Journal |
| issn | 2661-801X |
| language | English |
| last_indexed | 2024-04-09T23:11:51Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Chemistry |
| spelling | doaj.art-53341df3e8be4d28999b3bc79fb1743b2023-03-22T10:19:32ZengBMCBMC Chemistry2661-801X2023-03-0117111110.1186/s13065-023-00929-yMicellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testingNora A. Abdallah0Amina M. El-Brashy1Fawzia A. Ibrahim2Mohamed I. El-Awady3Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura UniversityDepartment of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura UniversityDepartment of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura UniversityDepartment of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura UniversityAbstract Background Cardiovascular disease medications such as aspirin (ASP), statins like atorvastatin (ATR), and blood pressure-lowering drugs including ACE inhibitors like ramipril (RAM) have been included in the World Health Organization (WHO) Essential Medicines List (EML) for many years. Therefore, there is a strong demand to develop a simple, rapid, and sensitive analytical method that can detect and quantitate the ternary mixture of these analytes in pharmaceutical preparations in a short run time. Lately, the analytical community focused on eliminating or reducing hazardous chemicals and solvents usage. Results A green, fast, selective, and cost-effective micellar HPLC method was established and validated for the concurrent determination of ternary combination of ASP, ATR, and RAM in the pure form and pharmaceutical preparations. Resolution of the three drugs was achieved by using a monolithic column and a micellar mobile phase consists of 0.3% triethylamine (TEA) in 90: 10 an aqueous solution of 0.12 M sodium dodecyl sulfate (SDS): n-propanol, (v/v). The pH was adjusted to 2.5 using orthophosphoric acid and a flow rate of 1.5 mL/min. was applied. To ensure method reproducibility, Valsartan (VAL) was utilized as an internal standard (IS). The UV detection of the studied drugs was performed at 210 nm. Good linearity for the three drugs was obtained over the concentration ranges of 1.0-200.0 mg/mL, 0.5-200.0 mg/mL, and 5.0-100.0 mg/mL with correlation coefficients of 0.9998,0.9999 and 0.9999 for ASP, ATR, and RAM respectively. The method sensitivity was revealed by the relatively small values of limits of detection (LOD) (0.19, 0.13 and 0.30 mg/mL) and limits of quantitation (LOQ) (0.63, 0.44 and 0.99 mg/mL) for ASP, ATR, and RAM, respectively. The retention times of ASP, ATR and RAM were 1.50, 2.3 and 4.3 min., respectively. Conclusions The suggested technique was employed for the analysis of the three drugs in their prepared tablets maintaining the recommended pharmaceutical ratio without any interference from excipients. The method was further extended to content uniformity testing of RAM. The results were validated according to international council for harmonisation (ICH) guidelines.https://doi.org/10.1186/s13065-023-00929-yMicellar HPLCAspirinAtorvastatinRamiprilLaboratory prepared tabletContent uniformity testing |
| spellingShingle | Nora A. Abdallah Amina M. El-Brashy Fawzia A. Ibrahim Mohamed I. El-Awady Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing BMC Chemistry Micellar HPLC Aspirin Atorvastatin Ramipril Laboratory prepared tablet Content uniformity testing |
| title | Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing |
| title_full | Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing |
| title_fullStr | Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing |
| title_full_unstemmed | Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing |
| title_short | Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing |
| title_sort | micellar eco friendly hplc method for simultaneous analysis of ternary combination of aspirin atorvastatin and ramipril application to content uniformity testing |
| topic | Micellar HPLC Aspirin Atorvastatin Ramipril Laboratory prepared tablet Content uniformity testing |
| url | https://doi.org/10.1186/s13065-023-00929-y |
| work_keys_str_mv | AT noraaabdallah micellarecofriendlyhplcmethodforsimultaneousanalysisofternarycombinationofaspirinatorvastatinandramiprilapplicationtocontentuniformitytesting AT aminamelbrashy micellarecofriendlyhplcmethodforsimultaneousanalysisofternarycombinationofaspirinatorvastatinandramiprilapplicationtocontentuniformitytesting AT fawziaaibrahim micellarecofriendlyhplcmethodforsimultaneousanalysisofternarycombinationofaspirinatorvastatinandramiprilapplicationtocontentuniformitytesting AT mohamedielawady micellarecofriendlyhplcmethodforsimultaneousanalysisofternarycombinationofaspirinatorvastatinandramiprilapplicationtocontentuniformitytesting |