Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability Tests
This study’s goal is to use a Box–Behnken design [BBD] methodology to create a new reverse-phase high-performance liquid chromatography diode-array detection [RP-HPLC-DAD] method for the simultaneous quantification of Amitriptyline and Propranolol in tablet dosages. The amitriptyline and propranolol...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-12-01
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| Online Access: | https://www.mdpi.com/2297-8739/9/12/421 |
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| author | Mohammad Khalid Sarfaraz Ahmad |
| author_facet | Mohammad Khalid Sarfaraz Ahmad |
| author_sort | Mohammad Khalid |
| collection | DOAJ |
| description | This study’s goal is to use a Box–Behnken design [BBD] methodology to create a new reverse-phase high-performance liquid chromatography diode-array detection [RP-HPLC-DAD] method for the simultaneous quantification of Amitriptyline and Propranolol in tablet dosages. The amitriptyline and propranolol standard drug peaks were obtained using a C-18 column with a dimension of 4.6 × 100 mm and a particle size packing of 2.5 µm at the retention time of 5.328 and 7.48 min, respectively. The mobile phase composition was a 75:25 mixture of methanol and 0.1 percent orthophosphoric acid, flowing at 1.0 mL/min at 26 °C. The peaks were identified at 257 nm after injecting 20 µL of the sample. An assay of the marketed tablets was performed, and the result was 101.33 and 99.4% for amitriptyline and propranolol, respectively, when compared to the standard calibration curve. Forced degradation investigations, such as acid, base, H<sub>2</sub>O<sub>2</sub>, and neutral condition, were performed. The results for both medications in term of % degradation were as follows: amitriptyline (16.07, 91.92, 26.98, and 0.64) and propranolol (15.84, 11.52, 9.09, and 3.62). According to the ICH criteria, the findings of the validation parameters were within an acceptable range. The new RP-HPLC-DAD method with BBD application is easy, accurate, and time-saving. |
| first_indexed | 2024-03-09T15:52:06Z |
| format | Article |
| id | doaj.art-f82788b0a017428084cae6a17360719d |
| institution | Directory Open Access Journal |
| issn | 2297-8739 |
| language | English |
| last_indexed | 2024-03-09T15:52:06Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
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| series | Separations |
| spelling | doaj.art-f82788b0a017428084cae6a17360719d2023-11-24T17:59:48ZengMDPI AGSeparations2297-87392022-12-0191242110.3390/separations9120421Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability TestsMohammad Khalid0Sarfaraz Ahmad1Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi ArabiaDepartment of Pharmacy Practice, College of Pharmacy, Jazan University, Jazan 45142, Saudi ArabiaThis study’s goal is to use a Box–Behnken design [BBD] methodology to create a new reverse-phase high-performance liquid chromatography diode-array detection [RP-HPLC-DAD] method for the simultaneous quantification of Amitriptyline and Propranolol in tablet dosages. The amitriptyline and propranolol standard drug peaks were obtained using a C-18 column with a dimension of 4.6 × 100 mm and a particle size packing of 2.5 µm at the retention time of 5.328 and 7.48 min, respectively. The mobile phase composition was a 75:25 mixture of methanol and 0.1 percent orthophosphoric acid, flowing at 1.0 mL/min at 26 °C. The peaks were identified at 257 nm after injecting 20 µL of the sample. An assay of the marketed tablets was performed, and the result was 101.33 and 99.4% for amitriptyline and propranolol, respectively, when compared to the standard calibration curve. Forced degradation investigations, such as acid, base, H<sub>2</sub>O<sub>2</sub>, and neutral condition, were performed. The results for both medications in term of % degradation were as follows: amitriptyline (16.07, 91.92, 26.98, and 0.64) and propranolol (15.84, 11.52, 9.09, and 3.62). According to the ICH criteria, the findings of the validation parameters were within an acceptable range. The new RP-HPLC-DAD method with BBD application is easy, accurate, and time-saving.https://www.mdpi.com/2297-8739/9/12/421RP-HPLC–DADBBDICH guidelinesstability studiesassay |
| spellingShingle | Mohammad Khalid Sarfaraz Ahmad Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability Tests Separations RP-HPLC–DAD BBD ICH guidelines stability studies assay |
| title | Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability Tests |
| title_full | Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability Tests |
| title_fullStr | Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability Tests |
| title_full_unstemmed | Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability Tests |
| title_short | Box–Behnken Design Used to Optimize the Simultaneous Quantification of Amitriptyline and Propranolol in Tablet Dosages by RP-HPLC-DAD Method and Their Stability Tests |
| title_sort | box behnken design used to optimize the simultaneous quantification of amitriptyline and propranolol in tablet dosages by rp hplc dad method and their stability tests |
| topic | RP-HPLC–DAD BBD ICH guidelines stability studies assay |
| url | https://www.mdpi.com/2297-8739/9/12/421 |
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