Author(s):
Rahul Godge, Ganesh Shinde, Rohini Gore
Email(s):
rahulgodge@gmail.com
DOI:
10.52711/0974-360X.2025.00465 
Address:
Rahul Godge*1, Ganesh Shinde2, Rohini Gore3
1Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Rahta, Ahmednagar - 413736, India.
2Department of Pharmaceutics, Institute of of Pharmacy, Loni KD, Rahta, Ahmednagar - 413713, India.
3Department of Mathematics, Pravara Rural Engineering College, Loni.
*Corresponding Author
Published In:
Volume - 18,
Issue - 7,
Year - 2025
ABSTRACT:
The main objective of this study is to develop a new and improved RPHPLC technique. It is sensitive and accurate and to identify mirabegron, solifenacin and their differences. A C18 (AGILENT) column is used to separate the drug and impurities by chromatography. The mobile phase consisted of 0.1% OPA and 25:75% vol/vol methanol along with TEA, pH 4.2. Results showed that mirabegron and solifenacin were successfully mixed and separated with respect to retention time. Collected at 5.521 and 9.162 min, respectively, when the flow rate was changed to 0.7 mL/min and detected at 231 nm using a UV detector. This graph shows the difference between mirabegron doses of 50-250 mcg/mL and solifenacin, 5-25 mcg/mL. Solifenacin and mirabegron increased the recovery rate from 101.46% to 101.12%. The certification process is based on the International Convention on Harmonized Standards. It achieved excellent results in terms of accuracy, precision, precision, linearity, specifications, and robustness. As a result, a strategy to successfully separate and combine solifenacin and mirabegron was successfully developed. This is a valid and reliable method for routine analysis of these substances in pharmaceutical formulations.
Cite this article:
Rahul Godge, Ganesh Shinde, Rohini Gore. Simultaneous Estimation of Solifenacin and Mirabegron in Bulk drug and Tablet Dosage Form by RP-HPLC Method. Research Journal of Pharmacy and Technology. 2025;18(7):3236-9. doi: 10.52711/0974-360X.2025.00465
Cite(Electronic):
Rahul Godge, Ganesh Shinde, Rohini Gore. Simultaneous Estimation of Solifenacin and Mirabegron in Bulk drug and Tablet Dosage Form by RP-HPLC Method. Research Journal of Pharmacy and Technology. 2025;18(7):3236-9. doi: 10.52711/0974-360X.2025.00465 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-7-45
REFERENCES:
1. Yadav PN, Chhalotiya UK. Quantification of β-Adrenergic Receptor Agonist Drug Mirabegron in Presence of Degradants by High Performance Thin Layer Chromatography. Analytical Chemistry Letters. 2021; 11(4): 512-522.
2. Morshedy S, Omran G. Validated sprectrofluorimetric method for determination of mirabegron by utilizing its quenching effect on acetoxymercuric fluorescein reagent. Spectrochimica Acta part A: Molecular and Biomolecular Spectroscopy, 2020; 239: 291-310. DOI: https://doi.org/1 0.1016/j.saa.2020.118509.
3. Roopa K P, Basavaiah K. Development and Validation of Spectrophotometric Methods for the Assay of Mirabegron in Bulk and Pharmaceutical Formulation. Journal of Applied Spectroscopy. 2021; 87:1171–1178. DOI: https://doi.org/10.1007/s10812-021-01126-2.
4. Shaik RP. Puttagunta SB. Analytical Method Development and Validation of Solifenacin in Pharmaceutical Dosage Forms by RP-HPLC. ISRN Analytical Chemistry. 2014; 2014: 1-5. DOI: https://doi.org/10.1155/2014/132020.
5. Srinivasarao, Y, Hemant Kumar, T. Simultaneous Estimation of Solifenacin Succinate and Tamsulosin Hydrochloride in Combined Dosage Form by Using First Order Derivative Spectrophotometric Method. Indian Journal of Pharmaceutical Sciences. 2021, 83(2), 331-335.
6. Bhavana V, Kumar HT. RP-HPLC Method For Estimation of Solifenacin Succinate in APT and Tablet Dosage Form. Asian Jornal of Pharmaceutical Analysis. 2019; 9(3):118-122. DOI: http://dx.doi.org/10.5958/2231-5675.2019.00022.X
7. Israel SD. Krishnachaitanya K. RP-HPLC Method for the Estimation of Tamsulosin and Solifenacin In Bulk And Its Dosage Forms. IJPSR. 2013; 4(11): 4343-4350. DOI: 10.13040/IJPSR.0975-8232.4(11).4343-50
8. A. Tanuja, S. Ganapaty. Stability Indicating RP-HPLC Method Development and Validation for the Determination of Solifenacin Succinate in Bulk and its Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2021; 14(7): 3509-4. doi: 10.52711/0974-360X.2021.00608
9. Packiaraj Jeyachandran Manohari. Development of commercially feasible and Cost-effective tablet of Solifenacin succinate that can be compounded into an oral suspension. Research Journal of Pharmacy and Technology. 2022; 15(9): 4166-2. doi: 10.52711/0974-360X.2022.00699
10. Teja DG, Dasu DC. Quantitative Analysis of Solifenacin Succinate in Pharmaceutical Dosage Form Using Uv Absorption Spectroscopy. JCPS. 2023; 6(3): 522-213.
11. Papanna RK, Kanakapura B. Determination of Solifenacin Succinate in Pure and Pharmaceutical Dosage forms by Spectrophotometry. Journal of Applied Spectroscopy. 2021; 76: 1262–1270. DOI: https://doi.org/10.1134/S1061934821110101
12. Abou El Alamin MM, Toubar SS. Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability indicating assay was examined. BMC Chemistry. 2023; 17(130): 1-18. DOI: https://doi.org/10.1186/s13065-023-01043-9
13. Shah DA, Tahilramani PJ. High-Performance Thin-Layer Chromatographic Method for the Estimation of Mirabegron and Solifenacin Succinate Used in the Treatment of Overactive Bladder Syndrome. JPC– Journal of Planar Chromatography – Modern TLC. 2019; 32: 323–327. DOI: https://doi.org/10.1556/1006.2019.32.4.7
14. Patel J, Patel G. Development and validation of UV and RP-HPLC method for simultaneous estimation of Mirabegron and Solifenacin succinate on their pharmaceutical dosage form. International Journal of Pharmaceutical and Bio-Medical Science. 2022; 02(08): 223-232. DOI: https://doi.org/10.47191/ijpbms/v2-i8-01
15. Kadam MM, Singh RP. Development and Validation of Stability indicating RPHPLC Method for the Quantitative Estimation of Mirabegron and Solifenacin Succinate in Pharmaceutical Dosage Form. Journal of Pharmaceutical Negative Results. 2022; 13(07): 6727-6737. DOI: https://doi.org/10.47750/pnr.2022.13.S07.815.
16. Patil, D.J., Godge, R.K., Jahagirdar, S.N., Mandhare, S.B. Validated Stability Indicating RP-HPLC Method for the Quantification of Process Related Impurities of Solifenacin and Mirabegron in Pharmaceutical Formulations. International Journal of Drug Delivery Technology. 2024; 14(1): 55–60
17. Godge RK., Shinde GS, Bhosale MS. RP-HPLC Method for estimation of Alogliptin and Glibenclamide in Synthetic mixture. Research J. Pharm. and Tech. 2020; 13(2): 555-559.
18. Rawan Alsayad, Antoun Laham. Investigation of the effects of some process variables on the Azithromycin Microencapsulation by the Quasi-Emulsion Solvent Evaporation Method. Research Journal of Pharmacy and Technology. 2023; 16(8): 3909-4. doi: 10.52711/0974-360X.2023.00643.
19. Sarika S. Malode, Milind P. Wagh. Formulation and Evaluation of Orodispersible Tablets Containing Taste Masked Mirabegron Resinate. Research Journal of Pharmacy and Technology. 2021; 14(9): 4736-2. doi: 10.52711/0974-360X.2021.00824
20. Bhat, L.R., Vora, A.T., Godge, R.K., Damle, M.C. Simultaneous estimation of nebivolol hydrochloride and amlodipine besylate in bulk and combined tablet dosage form by ultraviolet spectrophotometry. Indian Drugs. 2007; 44(12): 915–919.
21. Shashikant R Pattan, Rahul K Godge. Simultaneous Estimation of Ofloxacin and Satranidazole in Bulk and Dosage form by Ratio Spectra Derivative Spectroscopy. Research J. Pharm. and Tech. 2009; 2(3): 531-533.