Author(s):
Sandip Sen, Mitta Chaitanya, Bairam Ravindar, Kalepu Swathi, Rajasree Suram, Ameeduzzafar Zafar, Sowmya Perudi
Email(s):
sandipsen2010@gmail.com
DOI:
10.52711/0974-360X.2025.00746 
Address:
Sandip Sen1, Mitta Chaitanya2, Bairam Ravindar3, Kalepu Swathi2, Rajasree Suram4, Ameeduzzafar Zafar5, Sowmya Perudi3
1Department of Pharmaceutical Chemistry, School of Pharmacy, Guru Nanak Institutions Technical Campus, Ibrahimpattnam, Hyderabad - 501506, Telangana, India.
2Department of Pharmaceutical Chemistry, Bojjam Narasimhulu Pharmacy College for Women, Hyderabad - 500059, Telangana, India.
3Department of Pharmaceutical Analysis, Srikrupa Institute of Pharmaceutical Sciences, Velikatta, Kondapakka, Siddipet - 502277, India.
4Department of Pharmaceutical Analysis, Gyana Jyothi College of Pharmacy, Hyderabad - 500098, Telangana, India.
5Department of Pharmaceutics, College of Pharmacy, Jouf University, Sakaka 72341, Al-Jouf, Saudi Arabia.
*Corresponding Author
Published In:
Volume - 18,
Issue - 11,
Year - 2025
ABSTRACT:
Silodosin, an a-adrenoreceptor antagonist primarily prescribed for benign prostatic hyperplasia. The present investigation was aimed to establish and validate an RP-HPLC method to ensure stability assessment, applicable for quantifying the substance in bulk as well as capsule formulations. The USFDA approved this medication in August 2008 due to its high uroselectivity, specifically targeting the prostate. The RP-HPLC method was developed using a mobile phase Acetonitrile: Triethylamine buffer pH 4.6: Methanol (70:20:10) at a flow rate of 1ml/min. The retention time was 2.44 min. The validation procedures adhered to ICH guidelines. The method exhibited a linear response within the 10-50µg/ml range, demonstrating a regression coefficient of 0.999. The average percentage assay was determined to be within the range of 99.00-99.9%, validating the method. The percentage relative standard deviation (%RSD) remained below 2%. Stress studies revealed no noteworthy alterations in drug retention times, and additional peaks were observed during degradation conditions. This validated RP-HPLC method is deemed suitable for routine analysis and quantification of Silodosin in both its bulk and capsule dosage, providing a reliable method to determine drug content and degraded products.
Cite this article:
Sandip Sen, Mitta Chaitanya, Bairam Ravindar, Kalepu Swathi, Rajasree Suram, Ameeduzzafar Zafar, Sowmya Perudi. A Robust RP-HPLC Method for Silodosin in Bulk and Capsule Dosage Form: An Innovative Perspective on Stability Determination. Research Journal Pharmacy and Technology. 2025;18(11):5170-6. doi: 10.52711/0974-360X.2025.00746
Cite(Electronic):
Sandip Sen, Mitta Chaitanya, Bairam Ravindar, Kalepu Swathi, Rajasree Suram, Ameeduzzafar Zafar, Sowmya Perudi. A Robust RP-HPLC Method for Silodosin in Bulk and Capsule Dosage Form: An Innovative Perspective on Stability Determination. Research Journal Pharmacy and Technology. 2025;18(11):5170-6. doi: 10.52711/0974-360X.2025.00746 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-11-8
REFERENCES:
1. Rossi M, Roumeguère T. Silodosin in the treatment of benign prostatic hyperplasia. Drug Des Devel Ther. 2010; 4: 291-297. doi:10.2147/DDDT.S10428.
2. Goi Y, Tomiyama Y, Nomiya M, Sagawa K, Aikawa K, Yamaguchi O. Effects of silodosin, a selective α1A-adrenoceptor antagonist, on bladder blood flow and bladder function in a rat model of atherosclerosis-induced chronic bladder ischemia without bladder outlet obstruction. J Urol. 2013; 190(3): 1116-1122. doi:10.1016/j.juro.2013.03.110. PMID: 23545103.
3. Jindan L, Xiao W, Liping X. Evolving role of silodosin for the treatment of urological disorders - A narrative review. Drug Des Devel Ther. 2022; 16: 2861-2884. doi:10.2147/DDDT.S373659.
4. Jahan KK, Malipatil SM. Development and validation of new spectrophotometric methods for the quantitative estimation of silodosin in bulk drug and pharmaceutical formulations. Int J Pharm Res Anal. 2014; 4: 65-73.
5. Belal F, Sharaf El-Din MK, Eid MI, El-Gamal RM. Spectrofluorimetric determination of terbinafine hydrochloride and linezolid in their dosage forms and human plasma. J Fluoresc. 2013; 23: 1077-1087.
6. Shaik JV, Saladi S, Sait SS. Development of stability-indicating UHPLC method for the quantitative determination of silodosin and its related substances. J Chromatogr Sci. 2014; 52(7): 646-653. doi:10.1093/chromsci/bmt094.
7. Vali SJ, Saladi SK, Sait SS, Garg LK. Development and validation of LC method for determination of the enantiomeric purity of silodosin in bulk drug substances. Am J PharmTech Res. 2012; 2: 750-758.
8. Aneesh TP, Rajasekaran A. Development and validation of HPLC method for the estimation of silodosin in bulk and pharmaceutical dosage form. Int J Biol Pharm Res. 2012; 3: 693-710.
9. Sayana PS, Iyer RS, Shibi A, Harischandran S. Development and validation of HPTLC method for quantification of silodosin in the bulk and pharmaceutical dosage form. Pharma Innovation. 2012; 1: 60-65.
10. Shaik JV, Saladi S, Sait SS. Development of stability-indicating UHPLC method for the quantitative determination of silodosin and its related substances. J Chromatogr Sci. 2014; 52: 646-653.
11. Madelain V, Nguyen TH, Olivo A, et al. Ebola virus infection: review of the pharmacokinetic and pharmacodynamic properties of drugs considered for testing in human efficacy trials. Clin Pharmacokinet. 2016; 55(8): 907-923. doi:10.1007/s40262-015-0364-1. PMID: 26798032.
12. Prasad LAR, Rao JVLNS, Pamidi S, et al. New rapid UPLC method for the estimation of impurities in the capsule dosage form of silodosin. Int J Anal Bioanal Chem. 2012; 2: 247-251.
13. Zhao X, Liu Y, Xu J, et al. Determination of silodosin in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B. 2009; 877: 3724-3728.
14. Er E, Çelikkan H, Erk N, et al. A new generation electrochemical sensor based on graphene nanosheets/gold nanoparticles/Nafion nanocomposite for determination of silodosin. Electrochim Acta. 2015; 157: 252-257.
15. ICH Q2 (R1). International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical for Human Use. Validation of analytical procedures: text and methodology. Geneva, Switzerland; 2005.
16. Mohamad T. Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantification (LOQ). Org Med Chem Int J. 2018; 7(5): 555722. doi:10.19080/OMCIJ.2018.07.555722.
17. Kailasa Mangasree, Biswabara Roy, Harunrasheed Shaik, Sandip Sen. Analytical method development and validation of gemcitabine and clarithromycin in combined dosage form by RP-HPLC method. Indian Drug. 2021; 58(1): 76-78.
18. Boltia SA, Abdelkawy M, Mohammed TA, Mostafa NN. Validated stability-indicating spectrophotometric methods for the determination of silodosin in the presence of its degradation products. Spectrochim Acta A Mol Biomol Spectrosc. 2018; 202: 131-145. doi:10.1016/j.saa.2018.04.046.
19. Patel JK, Patel NK. Stability-indicating RP-HPLC method for the determination of ambrisentan and tadalafil in pharmaceutical dosage form. Sci Pharm. 2014; 82(4): 749-763. doi:10.3797/scipharm.1403-22.
20. Ganthi HK, Reddy R, Park YJ, et al. Stability-indicating HPLC method for quantification of solifenacin succinate and tamsulosin hydrochloride along with its impurities in tablet dosage form. Am J Anal Chem. 2016; 7(11): 840-862.
21. Nataraj KS, Rao AS, Harshitha S. Analytical method development and validation for the estimation of silodosin and dutasteride in capsule dosage form by RP-HPLC method. J Drug Metab Toxicol. 2020; 11: 245-252. doi:10.35248/2157-7609.20.11.245.
22. Chinnalalaiah R, Ravikumar P. Development and validation of RP-HPLC method for estimation of silodosin in bulk and pharmaceutical dosage forms. Int J Pharm Sci Rev Res. 2012; 16: 52-55.
23. Mishra S, Surekha N, Chauhan A. Development and validation of stability-indicating RP-HPLC method for simultaneous estimation of silodosin and mirabegron in synthetic mixture. Ann Pharm Fr. 2024; 82(2): 243-262. doi:10.1016/j.pharma.2023.12.013.