Araştırma Makalesi
Yıl 2021,
Cilt: 14 Sayı: 3, 993 - 1005, 18.12.2021
Öz
Destekleyen Kurum
Yok
Kaynakça
- Aneesh T P, Rajasekaran A. Method Development And Validation For The Estimation Of Sildosin In Bulk And Pharmaceutical Dosage Forms Using Uv-Vis Spectrophotometry. Asian J. Pharm. Clin. Res. 5.4: 150-152.
- Arslan-Alaton I, Tureli G, Olmez-Hanci T. 2009. Optimization of the photo-Fenton-like process for real and synthetic azo dye production wastewater treatment using response surface methodology. Photochem. Photobiol. Sci. 8, 628–638. doi:10.1039/b817423g
- Bezerra MA, Santelli RE, Oliveira EP, Villar LS, Escaleira LA. 2008. Response surface methodology (RSM) as a tool for optimization in analytical chemistry. Talanta 76, 965–977. doi:10.1016/j.talanta.2008.05.019
- Boltia SA, Abdelkawy M, Mohammed TA, Mostafa NN. 2018. Validated stability-indicating spectrophotometric methods for the determination of Silodosin in the presence of its degradation products. Spectrochim. Acta - Part A Mol. Biomol. Spectrosc. 202, 131–145. doi:10.1016/j.saa.2018.04.046 Er E, Erk N. 2016. An effective and sensitive stability-indicating chromatographic approach based on HPLC for silodosin assay. J.Anal.Sci.Technol. 7,20. doi:10.1186/s40543-016-0100-y
- Gavin PF, Olsen BA. 2008. A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603). J. Pharm. Biomed. Anal. 46, 431–441. doi:10.1016/j.jpba.2007.10.037
- Gunst RF. 1996. Response Surface Methodology: Process and Product Optimization Using Designed Experiments. Technometrics 38, 284–286. doi:10.1080/00401706.1996.10484509
- ICH Harmonised Tripartite Guideline Validation of Analytical Procedures: Text And Methodology Q2(R1) Retrieved from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2014
- International Conference On Harmonisation Of Technical Requirements For Registration of Pharmaceuticals For Human Use Pharmaceutical Development Q8(R2) (2009)
- Kishore P. 2012. Validated Estimation of Silodosin in Pure, Pharmaceuticals and in Biological Sample by UV-Spectroscopic and RP-HPLC Method. PhD Thesis, Adhiparasakthi College of Pharmacy, Melmaruvathur.
- Kurmi M, Singh B, Bhutani H, Singh S, Beg S. 2014. Quality by Design (QbD) in Analytical Sciences: An Overview. Quality Assurance. 3, 39.
- Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. 2009. Silodosin in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia: A 9-Month, Open-label Extension Study. Urology. 74, 1318–1322. doi:10.1016/j.urology.2009.06.072
- Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. 2013. Rapid efficacy of the highly selective α1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: Pooled results of 2 phase 3 studies. J. Urol. 189, S122–S128. doi:10.1016/j.juro.2012.11.020
- Nair SM, Kumar R, Sharma P, Karia M. 2016. Development and Validation of High Performance LCMS Methods for Estimation of Silodosin and Silodosin β-D-Glucuronide in Human Plasma. Pharm. Anal. Chem. 2, 118. doi:10.4172/2471-2698.1000118
- Orlandini S, Pinzauti S, Furlanetto S. 2013. Application of quality by design to the development of analytical separation methods. Anal. Bioanal. Chem. 405, 443–450. doi:10.1007/s00216-012-6302-2
- Peraman R, Bhadraya K, Reddy YP. 2015. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. Int. J. Anal. Chem. 2015, doi:10.1155/2015/868727
- Rajput SJ, Rajput DJ. 2014. Spectrofluorimetric Method For The Determination Of Silodosin In Bulk And Pharmaceutical Dosage Form. Indo Am. J. Pharm. Res. 4. Raman NVVSS, Reddy Mallu U, Reddy Bapatu H. 2015. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. J. Chem. doi:10.1155/2015/435129
- Roehrborn CG, Cruz F, Fusco F. 2017. α1-Blockers in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Obstruction: Is Silodosin Different? Adv. Ther. 33, 2110–2121. doi:10.1007/s12325-016-0423-5
- Sayana SP, Shankar Iyer R. 2012. Development and Validation of HPTLC Method for Quantification of Silodosin in Bulk and Pharmaceutical Dosage Form. The Pharma Innovation 1, 10.
- So PT, Dong CY. 2001. Fluorescence Spectrophotometry. In Encyclopedia of Life Sciences. Chichester, UK: John Wiley & Sons, Ltd. doi:10.1038/npg.els.0002978 Vogt FG, Kord AS. 2011. Development of quality-by-design analytical methods. J. Pharm. Sci. 100, 797–812. doi:10.1002/jps.22325
- Williams RT, Bridges JW. 1964. Fluorescence of Solutions: A Review. J. Clin. Pathol. 17, 371–394. doi:10.1136/jcp.17.4.371
- Yoshida M, Kudoh J, Homma Y, Kawabe K. 2011. Safety and efficacy of silodosin for the treatment of benign prostatic hyperplasia. Clin. Interv. Aging 6, 161–172. doi:10.2147/cia.s13803
- Zhao X, Liu Y, Xu J, Zhang D, Zhou Y, et al. 2009. Determination of silodosin in human plasma by liquid chromatography-tandem mass spectrometry. J J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 877, 3724–3728. doi:10.1016/j.jchromb.2009.08.025
Optimization of HPLC-FLD Conditions Using Analytical Quality by Design Approach for Quantification of Silodosin in Pharmaceutical Dosage Form
Öz
An HPLC-FLD method was developed using a surface response methodology for the quantification of silodosin in pharmaceuticals. The HPLC-FLD method was validated for accuracy, precision, working range, reproducibility, the limit of detection, the limit of quantification, and robustness. Analytical Quality by Design (AQbD) strategy was applied to develop an HPLC-FLD method for the quantification of silodosin in pharmaceuticals by using a central composite design methodology. Excitation and emission wavelengths with the highest fluorescence response for silodosin were determined by spectrofluorometric measurements at 256 nm and 456 nm, respectively. The parameters that have an impact on chromatographic separation and detection of silodosin were selected as pH, column temperature, and organic content of the mobile phase (acetonitrile %). A quadratic three-factor central composite design model consisting of 20 observations was used. The method showed good recovery and accuracy. The method was linear in the range of 0.1–40 µg/mL, with a high correlation coefficient (0.9991) and acceptable precision (RSD<7.8%). After validation studies, the optimized method was successfully applied in the analysis of silodosin-containing tablet formulation. The results demonstrated the robustness of the analytical method under the specified conditions. An HPLC-FLD method optimized for statistical tools was developed for analysis on silodosin pharmaceutical products. Using the AQbD approach has provided advantages in terms of time consumption and costs. The resulting method is fast with low analysis time and quite sensitive. We believe that the parameters optimized by the AQbD approach provide reliable conditions for the HPLC-FLD analysis of silodosin.
Anahtar Kelimeler
Silodosin analytical quality by design approach central composite design fluorescence detection pharmaceutical analysis
Kaynakça
- Aneesh T P, Rajasekaran A. Method Development And Validation For The Estimation Of Sildosin In Bulk And Pharmaceutical Dosage Forms Using Uv-Vis Spectrophotometry. Asian J. Pharm. Clin. Res. 5.4: 150-152.
- Arslan-Alaton I, Tureli G, Olmez-Hanci T. 2009. Optimization of the photo-Fenton-like process for real and synthetic azo dye production wastewater treatment using response surface methodology. Photochem. Photobiol. Sci. 8, 628–638. doi:10.1039/b817423g
- Bezerra MA, Santelli RE, Oliveira EP, Villar LS, Escaleira LA. 2008. Response surface methodology (RSM) as a tool for optimization in analytical chemistry. Talanta 76, 965–977. doi:10.1016/j.talanta.2008.05.019
- Boltia SA, Abdelkawy M, Mohammed TA, Mostafa NN. 2018. Validated stability-indicating spectrophotometric methods for the determination of Silodosin in the presence of its degradation products. Spectrochim. Acta - Part A Mol. Biomol. Spectrosc. 202, 131–145. doi:10.1016/j.saa.2018.04.046 Er E, Erk N. 2016. An effective and sensitive stability-indicating chromatographic approach based on HPLC for silodosin assay. J.Anal.Sci.Technol. 7,20. doi:10.1186/s40543-016-0100-y
- Gavin PF, Olsen BA. 2008. A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603). J. Pharm. Biomed. Anal. 46, 431–441. doi:10.1016/j.jpba.2007.10.037
- Gunst RF. 1996. Response Surface Methodology: Process and Product Optimization Using Designed Experiments. Technometrics 38, 284–286. doi:10.1080/00401706.1996.10484509
- ICH Harmonised Tripartite Guideline Validation of Analytical Procedures: Text And Methodology Q2(R1) Retrieved from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2014
- International Conference On Harmonisation Of Technical Requirements For Registration of Pharmaceuticals For Human Use Pharmaceutical Development Q8(R2) (2009)
- Kishore P. 2012. Validated Estimation of Silodosin in Pure, Pharmaceuticals and in Biological Sample by UV-Spectroscopic and RP-HPLC Method. PhD Thesis, Adhiparasakthi College of Pharmacy, Melmaruvathur.
- Kurmi M, Singh B, Bhutani H, Singh S, Beg S. 2014. Quality by Design (QbD) in Analytical Sciences: An Overview. Quality Assurance. 3, 39.
- Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. 2009. Silodosin in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia: A 9-Month, Open-label Extension Study. Urology. 74, 1318–1322. doi:10.1016/j.urology.2009.06.072
- Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. 2013. Rapid efficacy of the highly selective α1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: Pooled results of 2 phase 3 studies. J. Urol. 189, S122–S128. doi:10.1016/j.juro.2012.11.020
- Nair SM, Kumar R, Sharma P, Karia M. 2016. Development and Validation of High Performance LCMS Methods for Estimation of Silodosin and Silodosin β-D-Glucuronide in Human Plasma. Pharm. Anal. Chem. 2, 118. doi:10.4172/2471-2698.1000118
- Orlandini S, Pinzauti S, Furlanetto S. 2013. Application of quality by design to the development of analytical separation methods. Anal. Bioanal. Chem. 405, 443–450. doi:10.1007/s00216-012-6302-2
- Peraman R, Bhadraya K, Reddy YP. 2015. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. Int. J. Anal. Chem. 2015, doi:10.1155/2015/868727
- Rajput SJ, Rajput DJ. 2014. Spectrofluorimetric Method For The Determination Of Silodosin In Bulk And Pharmaceutical Dosage Form. Indo Am. J. Pharm. Res. 4. Raman NVVSS, Reddy Mallu U, Reddy Bapatu H. 2015. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. J. Chem. doi:10.1155/2015/435129
- Roehrborn CG, Cruz F, Fusco F. 2017. α1-Blockers in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Obstruction: Is Silodosin Different? Adv. Ther. 33, 2110–2121. doi:10.1007/s12325-016-0423-5
- Sayana SP, Shankar Iyer R. 2012. Development and Validation of HPTLC Method for Quantification of Silodosin in Bulk and Pharmaceutical Dosage Form. The Pharma Innovation 1, 10.
- So PT, Dong CY. 2001. Fluorescence Spectrophotometry. In Encyclopedia of Life Sciences. Chichester, UK: John Wiley & Sons, Ltd. doi:10.1038/npg.els.0002978 Vogt FG, Kord AS. 2011. Development of quality-by-design analytical methods. J. Pharm. Sci. 100, 797–812. doi:10.1002/jps.22325
- Williams RT, Bridges JW. 1964. Fluorescence of Solutions: A Review. J. Clin. Pathol. 17, 371–394. doi:10.1136/jcp.17.4.371
- Yoshida M, Kudoh J, Homma Y, Kawabe K. 2011. Safety and efficacy of silodosin for the treatment of benign prostatic hyperplasia. Clin. Interv. Aging 6, 161–172. doi:10.2147/cia.s13803
- Zhao X, Liu Y, Xu J, Zhang D, Zhou Y, et al. 2009. Determination of silodosin in human plasma by liquid chromatography-tandem mass spectrometry. J J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 877, 3724–3728. doi:10.1016/j.jchromb.2009.08.025
Toplam 22 adet kaynakça vardır.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Mühendislik |
| Bölüm | Makaleler |
| Yazarlar | |
| Yayımlanma Tarihi | 18 Aralık 2021 |
| Yayımlandığı Sayı | Yıl 2021 Cilt: 14 Sayı: 3 |