Author(s):
Avani N. Doshi, Vidhi Kotadiya, Patel Amita
Email(s):
avanidoshi20211@gmail.com
DOI:
10.52711/2231-5659.2026.00004 
Address:
Avani N. Doshi1, Vidhi Kotadiya2*, Patel Amita3
1Professor, K. B. Raval College of Pharmacy, Kasturinagar, Shertha, Gandhinagar, Gujarat.
2Associate Professor, K. B. Raval College of Pharmacy, Kasturinagar, Shertha, Gandhinagar, Gujarat.
3PG Scholar, K. B. Raval College of Pharmacy, Kasturinagar, Shertha, Gandhinagar, Gujarat.
*Corresponding Author
Published In:
Volume - 16,
Issue - 1,
Year - 2026
ABSTRACT:
The objective of this research is to design and validate a reliable Stability-Indicating RP-HPLC method for the simultaneous determination of Silodosin and Tadalafil in a synthetic mixture. A RP-HPLC method was established using an Agilent Eclipse XDB C18 column (150 mm × 4.5 mm ID × 5 µm) as the stationary phase. The mobile phase consisted of 0.1% TEA and ACN in a 60:40 (v/v) ratio. Sample injection was conducted at a flow rate of 1.0 mL/min, with detection set at a wavelength of 278 nm. Linearity within the concentration ranges of 40–120 µg/mL for Silodosin and 25–75 µg/mL for Tadalafil, with correlation coefficients (r²) of 0.9997 and 0.9996, respectively. Precision studies confirmed method repeatability, as the percentage relative standard deviation (% RSD) remained below 2%. Robustness assessment also demonstrated % RSD values under 2%, indicating the method's reliability despite minor variations in analytical conditions. Accuracy was validated through a recovery study, confirming the method's suitability for precise quantitative analysis. Validation was performed in accordance with the International Conference on Harmonization (ICH) guidelines, demonstrating excellent precision, accuracy, linearity, specificity, sensitivity, and robustness.
Cite this article:
Avani N. Doshi, Vidhi Kotadiya, Patel Amita. A Novel Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Silodosin and Tadalafil in its Synthetic Mixture. Asian Journal of Research in Pharmaceutical Sciences. 2026; 16(1):20-4. doi: 10.52711/2231-5659.2026.00004
Cite(Electronic):
Avani N. Doshi, Vidhi Kotadiya, Patel Amita. A Novel Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Silodosin and Tadalafil in its Synthetic Mixture. Asian Journal of Research in Pharmaceutical Sciences. 2026; 16(1):20-4. doi: 10.52711/2231-5659.2026.00004 Available on: https://www.ajpsonline.com/AbstractView.aspx?PID=2026-16-1-4
REFERENCES:
1. Naser M, Nasr MM, Shehata LH. Updates of Overactive Bladder (OAB) Management. Inter J Progressive Sci Technol.. 2020. https://www.westminsterclinic.ae/blog/overactive-bladder.
2. Krismanuel H, Tjhin P. Examining the effectiveness of Prostatic hyperplasia education on the level of participant’s knowledge and awareness. PLoS One. 2025 Jun 23; 20(6): e0325653.
3. Ng M, Leslie SW, Baradhi KM. Benign prostatic hyperplasia. InStatPearls [Internet] 2024 Oct 20. StatPearls Publishing.
4. Sacco E, Bientinesi R. Mirabegron: a review of recent data and its prospects in the management of overactive bladder. Therapeutic advances in urology. 2012 Dec; 4(6): 315-24.
5. Matsukawa Y, Takai S, Majima T, Funahashi Y, Sassa N, Kato M, Yamamoto T, Gotoh M. Comparison in the efficacy of fesoterodine or mirabegron add‐on therapy to silodosin for patients with benign prostatic hyperplasia complicated by overactive bladder: a randomized, prospective trial using urodynamic studies. Neurourology and Urodynamics. 2019 Mar; 38(3): 941-9.
6. Willard HH, Merritt Jr LL, Dean JA, Settle Jr FA. Introduction to Instrumental Methods of Analysis. CBS Publisher Distributors, New Delhi. 2001; 8: 580-654.
7. Skoog DA, West DM, Holler FJ, Crouch SR. Fundamentals of analytical chemistry. Fort Worth: Saunders College Pub.; 1996.
8. Guideline IH. Stability testing of new drug substances and products. Q1A (R2), Current Step. 2003 Feb; 4(1-24).
9. Runja C, Pigili R. 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: 52-5.
10. Shaik JV, Saladi S, Sait SS. Development of stability-indicating UHPLC method for the quantitative determination of silodosin and its related substances. Journal of Chromatographic Science. 2014 Aug 1; 52(7): 646-53.
11. Vishnuvardhan C, Saibaba B, Allakonda L, Swain D, Gananadhamu S, Srinivas R, Satheeshkumar N. LC–ESI–MS/MS evaluation of forced degradation behaviour of silodosin: In vitro anti cancer activity evaluation of silodosin and major degradation products. Journal of Pharmaceutical and Biomedical Analysis. 2017 Feb 5; 134: 1-0.
12. Rao JV, Hotha KK, Somerset L. New rapid UPLC method for the estimation of impurities in the capsule dosage form of silodosin.
13. Harischandran S, Iyer RS, Raju R, Shibi A, Sayana PS. Validated stability indicating RP-HPLC method for the determination of Silodosin in pharmaceutical dosage form. Inter. J. Pharma. Res. Sch. 2012; 1: 141-5.
14. Rao JV, Hotha KK, Somerset L. New rapid UPLC method for the estimation of impurities in the capsule dosage form of silodosin.
15. Goud VM, Rao AS, Ranjan SP, Shalini SD, Sowmya S, Bhoga B. Method development and validation of RP-HPLC method for assay of Sildosin in pharmaceutical dosage form. Inter. J. Pharma. Sci. 2013 Mar; 3: 194-6.
16. Sayana PS, Iyer RS, Shibi A, Harischandran S. Development and validation of HPTLC method for quantification of silodosin in bulk and pharmaceutical dosage form. The Pharma Innovation. 2012 Dec 1;1(10).
17. Tp AN, 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. 2012; 5(4): 150-2.
18. Tp AN, 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. 2012;5(4):150-2.
19. Paljashuva K, Ramarao N. Simultaneous estimation of dutasteride and silodosin in bulk form by RP-HPLC method. World Journal of Current Medical and Pharmaceutical Research. 2019 Oct 31:148-63.
20. Gupta A, Mishra SK. A novel analytical method for simultaneous quantification of silodosin and tadalafil by RP-HPLC. J. Pharm. Res. Int. 2021; 33: 193-202.
21. “Pharmacopoeia I. The Indian pharmacopoeia commission. Central Indian Pharmacopoeia Laboratory, Ministry of Health and Family Welfare, Govt of India, Sector. 2007;23.
22. Pharmacopoeia I. The Indian Pharmacopoeia Commission Ghaziabad Vol.
23. Vyas AJ, Gol DA, Patel AI, Patel AB, Patel NK, Chudasama A. A stress degradation kinetic study of Tadalafil bulk and tablet dosage form by UV Spectrophotometry. Asian Journal of Pharmaceutical Analysis. 2020; 10(4): 177-81.
24. Ahmed NR. High performance liquid chromatographic method for determination of tadalafil in tablets and wastewater. Iraqi Journal of Pharmacy. 2014; 14(1): 87-94.
25. Bhadoriya A, Dasandi B, Parmar D, Shah PA, Shrivastav PS. Quantitation of tadalafil in human plasma using a sensitive and rapid LC-MS/MS method for a bioequivalence study. Journal of pharmaceutical analysis. 2018 Aug 1;8(4):271-6.
26. Farthing CA, Farthing DE, Koka S, Larus T, Fakhry I, Xi L, Kukreja RC, Sica D, Gehr TW. A simple and sensitive HPLC fluorescence method for determination of tadalafil in mouse plasma. Journal of Chromatography B. 2010 Oct 15; 878(28): 2891-5.
27. Aboul-Enein HY, Ali I. Determination of tadalafil in pharmaceutical preparation by HPLC using monolithic silica column. Talanta. 2005 Jan 15; 65(1): 276-80.
28. Bhadoriya A, Dasandi B, Parmar D, Shah PA, Shrivastav PS. Quantitation of tadalafil in human plasma using a sensitive and rapid LC-MS/MS method for a bioequivalence study. Journal of Pharmaceutical Analysis. 2018 Aug 1; 8(4): 271-6.
29. Farthing CA, Farthing DE, Koka S, Larus T, Fakhry I, Xi L, Kukreja RC, Sica D, Gehr TW. A simple and sensitive HPLC fluorescence method for determination of tadalafil in mouse plasma. Journal of Chromatography B. 2010 Oct 15; 878(28): 2891-5.
30. Rezk MR, Abdel‐Moety EM, Wadie M, Tantawy MA. Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods. Journal of Separation Science. 2021 Jan; 44(2): 530-8.
31. Giri AD, Bhusari VK, Dhaneshwar SR. Validated HPLC method for simultaneous quantitation of tadalafil and dapoxetine hydrochloride in bulk drug and formulation. Int J Pharm Pharm Sci. 2012; 4(2): 654-8.
32. Khatal PH, D’souza K, Syeda A, Muddukrishna BS, Vasantharaju SG. Stability Indicating Assay Method for Simultaneous Estimation of Tadalafil and Dapoxetine Hydrochloride by RP-HPLC in Bulk. Latin American Journal of Pharmacy. 2021 Jan 1; 40(1): 49-56.
33. Gupta A, Mishra SK. A novel analytical method for simultaneous quantification of silodosin and tadalafil by RP-HPLC. J. Pharm. Res. Int. 2021; 33: 193-202.
34. Dave VS, Patel PU. Development and validation of simultaneous estimation of canagliflozin and metformin by Q absorbance ratio method in its API and tablet formulation. Research Journal of Pharmacy and Technology. 2022; 15(10): 4637-40.
35. Vidhi D, Patel P. Method development and validation of UV spectrophotometric estimation of remogliflozin etabonate in bulk and its tablet dosage form. Research Journal of Pharmacy and Technology. 2021; 14(4): 2042-4.
36. Suneetha A, Sekhar BC, Babu KS. DOE assisted RP-HPLC method development and validation for estimation of L-Cysteine and Cystine with Dansyl chloride derivatization in presence of amino acid mixture. Asian Journal of Pharmaceutical Analysis. 2022; 12(1): 35-42.
37. Vyas AJ, Vadile HM, Patel AI, Patel AB, Dudhrejiya AV, Shah SR, Chotaliya UJ, Sheth DB. Recent Applications of UV-Visible Derivative Spectroscopic Method. Asian Journal of Pharmaceutical Analysis. 2023; 13(2): 108-14.
38. Vyas AJ, Patel SM, Patel AB, Patel AI, Patel NK, Shah S, Sheth D. Stability testing: An Essential study for Vaccine Formulation Development. Asian Journal of Pharmaceutical Research. 2022;12(1):29-36.
39. Patel DB, Patel NJ. Validated reversed-phase high-performance liquid chromatographic and high-performance thin-layer chromatographic methods for simultaneous analysis of tamsulosin hydrochloride and dutasteride in pharmaceutical dosage forms. Acta Chromatographica. 2010 Sep 1; 22(3): 419-31.
40. Vyas AJ, Pithiya BS, Ramani A, Patel AI, Patel NK, Dudhrejiya AV, Shah SR, Gavit HB. Stability indicating RP-HPLC method for simultaneous estimation of Dutasteride and Silodosin used for the treatment of Benign Prostatic Hyperplasia.
41. Nataraj KS, Srinivasa RA, 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): 1-8.
42. Harischandran S, Iyer RS, Raju R, Shibi A, Sayana PS. Validated stability indicating RP-HPLC method for the determination of Silodosin in pharmaceutical dosage form. Inter. J. Pharma. Res. Sch. 2012; 1: 141-5.
43. Jagadeesh KA, Kadiyala KG, Varma Dendukuri BN, Guttula RS, Gupta Tiruveedhi VL, Vamsi PE. Quality control assessment of dutasteride and silodosin in capsules and tablets employing a novel developed HPLC technique; evaluation of stabilities of dutasteride and silodosin in accelerated degradation. International Journal of Applied Pharmaceutics. 2023 Sep 12; 15(6):98-107.