Author(s):
Md. Abid Hasan, Naima Helal, Sajia Azmi, Nursad Jahan Sultana, Sumaya Sarmina Nasir, Rehnuma Jafreen, Md Shadman Khan, Zobayda Islam Juthi, Kazi Jannatun Nayeem
Email(s):
mdabid780@gmail.com
DOI:
10.52711/0974-360X.2024.00666 
Address:
Md. Abid Hasan1,3*, Naima Helal1,2, Sajia Azmi3, Nursad Jahan Sultana3, Sumaya Sarmina Nasir3, Rehnuma Jafreen4, Md Shadman Khan3, Zobayda Islam Juthi2, Kazi Jannatun Nayeem3
1Department of Pharmacy, University of Asia Pacific, Dhaka, 1205, Bangladesh.
2Department of Pharmacy, World University of Bangladesh, Dhaka, 1230, Bangladesh.
3Department of Pharmacy, University of Science and Technology, Chittagong, Chattogram, 4202, Bangladesh.
4Department of Pharmacy, Jahangirnagar University, 1342, Bangladesh.
*Corresponding Author
Published In:
Volume - 17,
Issue - 9,
Year - 2024
ABSTRACT:
Benign prostatic hyperplasia is commonly treated with silodosin, a selective 1-adrenoreceptor antagonist. The goal is to create a straightforward and accurate high performance liquid chromatographic technique for silodosin detection and validate it in accordance with ICH standards. Agilent HPLC 1260 Infinity series was used and empower software was utilized for data processing. On a Cyano; 4.6mm × 25cm; 5mm, packing USP Octadecyl Silane column, silodosin was successfully separated by using mobile phase, made up of a mixer of 4.0 pH ammonium acetate buffer: Acetonitrile: Methanol (30:30:40) at 1.0ml/min flow rate and at a wavelength of 270 nm.The silodosin responded at 3.9minutes. The validation parameters including specificity, LOD/LOQ, linearity, accuracy, precision, robustness, and solution stability, were verified for performance of the method. All the peaks were well separated and there was no interference. Correlation coefficient of silodosin was 1.00, which indicated the method maintain linearity at different concentration. In precision study, the cumulative %RSD of silodosin was 0.88. The percent recovery of the silodosin at different concentration was within the (98.0-102.0) %. When the column temperature was increased/decreased by 3°C from the real and the flow rate was increased/decreased by 0.2mL/min from the actual rate, the system suitability resolution was still within the acceptable range. The standard and sample solution were stable after 24 hours at both room temperature and 5°C temperature. For the analysis of silodosin in pharmaceutical goods, the confirmed HPLC method may be a workable analytical approach.
Cite this article:
Md. Abid Hasan, Naima Helal, Sajia Azmi, Nursad Jahan Sultana, Sumaya Sarmina Nasir, Rehnuma Jafreen, Md Shadman Khan, Zobayda Islam Juthi, Kazi Jannatun Nayeem. Development of an Convenient and Robust Analytical Technique for HPLC-based Determination of Silodosin in Capsule Formulation. Research Journal of Pharmacy and Technology. 2024; 17(9):4311-7. doi: 10.52711/0974-360X.2024.00666
Cite(Electronic):
Md. Abid Hasan, Naima Helal, Sajia Azmi, Nursad Jahan Sultana, Sumaya Sarmina Nasir, Rehnuma Jafreen, Md Shadman Khan, Zobayda Islam Juthi, Kazi Jannatun Nayeem. Development of an Convenient and Robust Analytical Technique for HPLC-based Determination of Silodosin in Capsule Formulation. Research Journal of Pharmacy and Technology. 2024; 17(9):4311-7. doi: 10.52711/0974-360X.2024.00666 Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-9-27
REFERENCES:
1. Committee AUA P G. AUA guideline on management of benign prostatic hyperplasia (2003) Chapter 1: Diagnosis and treatment recommendations. The Journal of Urology. 2003; Aug; 170(2 pt 1): 530-547. doi.org/10.1097/01.ju.0000078083.38675.79
2. Wasserman N F. Benign prostatic hyperplasia: A review and ultrasound classification. Radiologic Clinics of North America. 2006; Sep; 44(5): 689-710.doi.org/10.1016/j.rcl.2006.07.005.
3. Thorpe A, Neal P D. Benign prostatic hyperplasia. The Lancet. 2003; 362(9366): 1359-1367. doi.org/10.1016/S0140-6736(03)13073-5
4. Rossi M, Roumeguere T. Silodosin if the treatment of benign prostatic hyperplasia. Drug design, development and therapy. 2010; 4: 291-297. doi.org/10.2147/DDDT.S10428
5. Marks L S, Gittelman M C, Hill L A, Volinn W, Hoel G. Silodosin in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia: A 9-Month, Open-label Extension Study. Urology. 2009; 74: 1318–1322. doi: 10.1016/j.urology.2009.06.072
6. Roehrborn C G, Cruz F, Fusco F. α1-Blockers in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Obstruction: Is Silodosin Different? Advances in Therapy. 2017; 33: 2110–2121. doi:10.1007/s12325-016-0423-5
7. Yoshida M, Kudoh J, Homma Y, Kawabe K. Safety and efficacy of silodosin for the treatment of benign prostatic hyperplasia. Clinical Interventions in Aging. 2011; 6: 161–172. doi: 10.2147/cia.s13803
8. Er E, Erk N. An effective and sensitive stability-indicating chromatographic approach based on HPLC for silodosin assay. Journal of Analytical Science and Technology. 2016; 7:20. doi.org/10.1186/s40543-016-0100-y
9. Zhao X, Liu Y, Xu J, Zhang D, Zhou Y, Gu J, Cui Y. Determination of silodosin in human plasma by liquid chromatography-tandem mass spectrometry. Journal of Chromatography B. 2009; 877(29): 3724–3728. doi.org/10.1016/j.jchromb.2009.08.025
10. Harischandran S, Shankar L R, Raju R, Shibi A, Sayana P S. Method development and validation RP-HPLC method for assay of silodosin in pharmaceutical dosage form. International Journal of Pharmaceutical Sciences and Research. 2012; 1(4): 141–145.
11. Yaman M E, Akman T C. Optimization of HPLC-FLD Conditions Using Analytical Quality by Design Approach for Quantification of Silodosin in Pharmaceutical Dosage Form. Erzincan University Journal of Science and Technology. 2021; 14 (3): 993-1005. doi.org/10.18185/erzifbed.955967
12. Yadlapalli S S R, Katari N K, Manabolu S B, Ravi V B. Simultaneous estimation of silodosin and silodosin β-Dglucuronide in human plasma using LC-MS/MS for a pharmacokinetic study. Journal of Taibah University for Science. 2018; 12 (4): 393-400. doi.org/10.1080/16583655.2018.1490562
13. Nataraj KS, Srinivasa R A, Harshitha S, Pravallika K. Analytical Method Development and Validation for the Estimation of Silodosin and Dutasteride in Capsule Dosage Form by RP-HPLC Method. Journal of Drug Metabolism & Toxicology. 2020; 11(2): 245. 10.35248/2157-7609.20.11.245
14. Shah H P, Khandar A, Deshpande S, Bagade S. Novel RP-HPLC method for simultaneous estimation of silodosin and dutasteride in multiunit solid dosage form. Research Journal of Pharmaceutical, Biological and Chemical Sciences. 2014; 5(2): 801-810.
15. Gupta A, Mishra S K. A Novel Analytical Method for Simultaneous Quantification of Silodosin and Tadalafil by RP-HPLC. Journal of Pharmaceutical Research International. 2021; 33(39B): 193-202. doi.org/10.9734/jpri/2021/v33i39B32195
16. Shaik J V, Saladi S, Sait S S. Development of Stability-Indicating UHPLC Method for the Quantitative Determination of Silodosin and Its Related Substances. Journal of Chromatographic Science. 2014; 52(7): 646–653. doi.org/10.1093/chromsci/bmt094
17. Ahmed S, Abdelkawy M, Mohamed T A, Nasser N. Validated stability-indicating spectrophotometric methods for the determination of Silodosin in the presence of its degradation products.Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2018; 202: 131–145. doi.org/10.1016/j.saa.2018.04.046
18. Mounika C H, Umadevi N, Sudheerbabu I. New visible spectrophotometric for the estimation of silodosin in pharmaceutical formulations. International Journal of Research in Pharmacy and Chemistry. 2013; 3(3): 595–597.
19. Aneesh T P, Aiyalu R. Method development and validation for the estimation of silodosin in bulk and pharmaceutical dosage forms using UV-VIS spectrophotometry. Asian Journal of Pharmaceutical and Clinical Research. 2012; 5(4): 4–6.
20. Bhamre P, Rajput S J. Spectrofluorimetric method for the determination of silodosin in bulk and pharmaceutical dosage form. Indo American Journal of Pharmaceutical Research. 2014; 4(10): 5106–5110.
21. Toker B, Er E, Erk N. Development of voltammetric techniques for the determination of silodosin in pharmaceutical formulation at glassy carbon electrode. Revue Roumaine de Chimie. 2014; 59(5): 311–316.
22. Er E, Celikkan H, Erk, N. An ultra-sensitive 2D electrochemical sensor based on a PtNPs@graphene/Nafion nanocomposite for determination of α1-AR antagonist silodosin in human plasma. Analytical Methods. 2017; 9: 3782–3789.
23. Mahmoud M. Sebaiy, Abdullah A. El-Shanawany, Sobhy M. El-Adl, Lobna M. Abdel-Aziz, Hisham A. Hashem. Rapid RP-HPLC Method for Simultaneous Estimation of Norfloxacin and Tinidazole in Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(4): Oct. - Dec. 79-84.
24. L. Satyanarayana, S.V. Naidu, M. Narasimha Rao, Reddy Suma Latha. The Estimation of Nilotinib in Capsule dosage form by RP-HPLC. Asian J. Pharm. Ana. 2011; 1(4): 100-102.
25. Sharmin Reza Chowdhury, Mahfuza Maleque, Mahbubul Hoque Shihan. Development and Validation of a Simple RP-HPLC Method for Determination of Caffeine in Pharmaceutical Dosage Forms. Asian J. Pharm. Ana. 2012; 2(1): 1-4.
26. P. Janaki Pathi, N. Appala Raju. The Estimation of Epalrestat in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(2): 49-51.
27. Y Rajendraprasad, KK Rajasekhar, V Shankarananth, S Bharath kumar, G Dileep kumar, T Sreelekha. RP-HPLC Method for the Estimation of Domperidone in Bulk and Pharmaceutical Formulations. Asian J. Research Chem. 2009; 2(4): 561-564.
28. K Ananda kumar, G Kumaraswamy, T Ayyappan, ASK Sankar, D Nagavalli. Validated RP-HPLC Method for the Estimation of Eszopiclone in Bulk and Tablet Dosage Form. Asian J. Research Chem. 2010; 3(1): 63-66.
29. Antakli S, Alahmad A, Badingki H. Simultaneous Determination of Sodium Benzoate and Potassium Sorbate Preservatives in Foodstuffs Using High-Performance Liquid Chromatography. Asian J. Research Chem. 2010; 3(1): 178-182.
30. Amrish Sharma, Mukul Tailang, Bhaskar Gupta, Ashish Acharya. RP HPLC Determination of Amlodipine in Its Pharmaceutical Dosage Forms. Asian J. Research Chem. 2010; 3(1): 129-131.
31. Prabhu S, Vijay Amirtharaj R, Senthilkumar N. Simultaneous RP-HPLC Method Development and Validation of Cefixime and Ofloxacin in Tablet Dosage Form. Asian J. Research Chem. 2010; 3(2): 367-369.
32. T.M. Kalyankar, R.B. Kakde. Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Metformin and Repaglinide in Pharmaceutical Preparations. Research J. Pharma. Dosage Forms and Tech. 2011; 3(5): 233-237.
33. Shalini Pant, Krishan Pal. Development and Validation of a Simultaneous HPLC Method for Assay and Dissolution of Bisoprolol fumarate and Amlodipine besylate in Pharmaceutical Dosage. Research J. Pharma. Dosage Forms and Tech. 2012; 4(1): 62-66,
34. N Appala Raju, Shabana Begum. Simultaneous RP-HPLC Method for the Estimation of the Emtricitabine, Tenofovir Disoproxil Fumerate and Efavirenz in Tablet Dosage Forms. Research J. Pharm. and Tech. 2008; 1(4): 522-525.
35. Akash Shelke, Someshwar Mankar, Mahesh Kolhe. Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form. Research Journal of Science and Technology. 2021; 13(2): 100-4.
36. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q2 (R1). Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization (ICH), Geneva, Switzerland. 2005 November.
37. U.S. Pharmacopeial Convention. The U.S. Pharmacopoeia (USP 43), National Formulary (NF 38) General Chapters: 1225. Validation of Compendial Procedures. Rockville. 2020.