Validation of UV spectrophotometric method for estimation of bedaquiline fumarate in bulk and pharmaceutical formulations
Öz
The FDA-approved diaryl-quinoline anti-mycobacterial drug called bedaquiline fumarate is used to treat pulmonary multi drug resistant tuberculosis. It inhibits proton pump of mycobacterial ATP synthase, an enzyme necessary for production of energy in mycobacterium tuberculosis bacteria. According to ICH Q2(R1) guideline, this research presents simple, rapid, reproducible and cost-effective UV spectrophotometric method for estimation of bedaquiline fumarate in bulk and pharmaceutical formulations. Phosphate buffer pH 7.4 was selected as solvent for the measurement of λmax at 200nm-400nm wavelength range and further investigated for Linearity, Accuracy, Ruggedness, Intraday and Interday Precision, Limit of quantification (LOQ) and limit of detection (LOD). The λmax in phosphate buffer pH 7.4 was found to be 285.88nm and the method was discovered to be linear over the range of 10μg/ml-70μg/ml with R2 value of 0.9974. After the concentration spikes of 80%, 100%, and 120% in the accuracy study, the mean %recovery was determined to be 101.18%, 100.95%, and 100.60%, respectively, and %RSD was less than 2.0%. For the 10μg/ml sample solution, there was no appreciable difference in the data from two independent analysts. The suggested method was therefore thought to be reproducible and rugged. Intraday and interday precision were demonstrated with less than 2.0%RSD. The Limit of quantification (LOQ) was determined to be 3.884μg/ml and the limit of detection (LOD) to be 1.282μg/ml. The assay of bedaquiline fumarate didn’t interfere by the excipients used in the formulation of inhaled dry powder of bedaquiline fumarate loaded nano structured lipid carrier (NLC) capsules 50mg. This method is useful for routine analysis of bedaquiline fumarate in bulk and pharmaceutical formulations.
Anahtar Kelimeler
Bedaquiline Fumarate UV Spectrophotometry bedaquiline fumarate loaded NLC DPI ICH Q2(R1) Guideline
Kaynakça
- [1] Rajiv M. Bedaquiline: First FDA-approved tuberculosis drug in 40 years. Int J Appl Basic Med Res 2013; 3(1): 1-2. https://doi.org/10.4103/2229-516X.112228
- [2] Kakkar AK, Dahiya N. Bedaquiline for the treatment of resistant tuberculosis: promises and pitfalls. Tuberculosis 2014; 94(4): 357-362. https://doi.org/10.1016/j.tube.2014.04.001
- [3] Pubchem. National Library of Medicine. Bedaquiline Fumarate. https://pubchem.ncbi.nlm.nih.gov/compound/Bedaquiline-fumarate (Accessed on 16 September 2023).
- [4] Centre for Drug Evaluation and Research. Clinical Pharmacology and Biopharmaceutics Reviews. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000ClinPharmR.pdf (Accessed on 16 September 2023).
- [5] Ganesh S, Godage RK, Jadhav RS, Manoj B, Aniket B. A review on advance in UV spectroscopy. Res J Sci Tech 2020; 12(1): 47-51. https://doi.org/10.5958/2349-2988.2020.00005.4
- [6] Passos MLC, Saraiva MLMFS. Detection of UV-visible spectrophotometry: Detectors, detection system and detection strategies. Measurement 2019; 135: 896-904. https://doi.org/10.1016/j.measurement.2018.12.045
- [7] European Pharmacopoeia 5.0. Buffer Solution. file:///C:/Users/Priya/Downloads/4.1.3.Buffersolutions.pdf (Accessed on 16 September 2023).
- [8] International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf (Accessed on 16 September 2023).
- [9] Shinde KP, Rajmane AD. A review UV method development and validation. Asian J Pharm Anal. 2023; 13 :2-10. https://doi.org/10.52711/2231-5675.2023.00021
- [10] Atole DM, Rajput HH. Ultraviolet spectroscopy and its pharmaceutical application- a brief review. Asian J Pharm Clin Res. 2018; 11: 59-66. https://doi.org/10.22159/ajpcr.2018.v11i2.21361
- [11] Pooja BS, Shetty ASK. Development and validaton of UV spectrophotometric methods for the estimation of bedaquiline in bulk and pharmaceutical formulations. World J Pharm Res. 2018; 7: 1579-1586. https://doi.org/10.20959/wjpr20187-11139
Öz
Kaynakça
- [1] Rajiv M. Bedaquiline: First FDA-approved tuberculosis drug in 40 years. Int J Appl Basic Med Res 2013; 3(1): 1-2. https://doi.org/10.4103/2229-516X.112228
- [2] Kakkar AK, Dahiya N. Bedaquiline for the treatment of resistant tuberculosis: promises and pitfalls. Tuberculosis 2014; 94(4): 357-362. https://doi.org/10.1016/j.tube.2014.04.001
- [3] Pubchem. National Library of Medicine. Bedaquiline Fumarate. https://pubchem.ncbi.nlm.nih.gov/compound/Bedaquiline-fumarate (Accessed on 16 September 2023).
- [4] Centre for Drug Evaluation and Research. Clinical Pharmacology and Biopharmaceutics Reviews. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000ClinPharmR.pdf (Accessed on 16 September 2023).
- [5] Ganesh S, Godage RK, Jadhav RS, Manoj B, Aniket B. A review on advance in UV spectroscopy. Res J Sci Tech 2020; 12(1): 47-51. https://doi.org/10.5958/2349-2988.2020.00005.4
- [6] Passos MLC, Saraiva MLMFS. Detection of UV-visible spectrophotometry: Detectors, detection system and detection strategies. Measurement 2019; 135: 896-904. https://doi.org/10.1016/j.measurement.2018.12.045
- [7] European Pharmacopoeia 5.0. Buffer Solution. file:///C:/Users/Priya/Downloads/4.1.3.Buffersolutions.pdf (Accessed on 16 September 2023).
- [8] International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf (Accessed on 16 September 2023).
- [9] Shinde KP, Rajmane AD. A review UV method development and validation. Asian J Pharm Anal. 2023; 13 :2-10. https://doi.org/10.52711/2231-5675.2023.00021
- [10] Atole DM, Rajput HH. Ultraviolet spectroscopy and its pharmaceutical application- a brief review. Asian J Pharm Clin Res. 2018; 11: 59-66. https://doi.org/10.22159/ajpcr.2018.v11i2.21361
- [11] Pooja BS, Shetty ASK. Development and validaton of UV spectrophotometric methods for the estimation of bedaquiline in bulk and pharmaceutical formulations. World J Pharm Res. 2018; 7: 1579-1586. https://doi.org/10.20959/wjpr20187-11139
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | İlaç Dağıtım Teknolojileri |
| Bölüm | Articles |
| Yazarlar | |
| Yayımlanma Tarihi | 28 Haziran 2025 |
| Yayımlandığı Sayı | Yıl 2024 Cilt: 28 Sayı: 4 |