International Journal of Drug Delivery Technology
Volume 14, Issue 1

Validated Stability Indicating RP-HPLC Method for the Quantification of Process Related Impurities of Solifenacin and Mirabegron in Pharmaceutical Formulations

D J Patil, R K Godge*, S N Jahagirdar, S B Mandhare

Department of Quality Assurance, Pravara Rural College of Pharmacy Pravaranagar, Tal-Rahata, Ahmednagar, Maharashtra, India. 

Received: 10th November, 2023; Revised: 18th December, 2023; Accepted: 04th January, 2024; Available Online: 25th March, 2024

ABSTRACT

To assess solifenacin (SOL) and mirabegron (MER) simultaneously, a verified reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed to indicate stability. The method was thoroughly evaluated and found to meet satisfactory criteria for precision, linearity, accuracy, limits on detection, and robustness, limits on quantitation. The quantitation wavelength of 231 nm was determined. Linearity was successfully demonstrated across concentration ranges of 5 to 25 µg/mL of solifenacin and 50 to 250 µg/mL of mirabegron. RPHPLC separations was conducted employing a Phenomenex L. C18 column measuring 250 x 4.6 mm and containing particles as small as 5 µm. The methanol and phosphate buffer (pH 7) were combined in a volumetric ratio of 25:75 to create the mobile phase. The separation is accomplished at a 0.7 mL per minute flow rate. Time spent in retention for mirabegron and solifenacin had been established at 5.521 and

9.161 minutes, respectively. Forced degradation studies validated the stability-indicating character of the approach, which included hydrolysis under acidic and basic conditions, exposure to H2O2, thermal degradation, and photodegradation. Mirabegron and solifenacin exhibited 10 to 20% degradation under the specified conditions. Importantly, the process evaluated the two prescription drugs in detail with all degradation products generated during the forced degradation experiments. This developed method is characterized as straightforward, specific, and cost-effective, making them suitable of the simultaneous estimate of mirabegron with solifenacin in tabs dose forms.

Keywords: Solifenacin, Mirabegron, RPHPLC technique, Validation, Forced degradation.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.10

How to cite this article: Patil DJ, Godge RK, Jahagirdar SN, Mandhare SB. 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.

REFERENCES

  1. Suryawanshi R, Shaikh RP-HPLC Method Development and Validation for the estimation of Mirabegron in Bulk and Dosage Form. Journal of Drug Delivery & Therapeutics. 2020;10(1): 31-38. http://dx.doi.org/10.22270/jddt.v10i1.3841
  2. Sankar PR, Kishore Analytical Method Development and Validation for the determination of Mirabegron in pharmaceutical dosage form by Rp-Hplc. International Journal of Pharmaceutical Sciences and Research. 2020;11(5):2223-2228. http://doi.org/10.13040/IJPSR.0975-8232.11(5).2223-28.
  3. Yadav PN, Chhalotiya UK. Quantification of β-Adrenergic Receptor Agonist Drug Mirabegron in Presence of Degradants by High Performance Thin Layer Chromatography. Analytical Chemistry 2021;11(4):512-522. https://doi.org/10.1080/2 2297928.2021.1938216
  4. Morshedy S, Omran 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. https://doi.org/10.1016/j.saa.2020.118509.
  5. Roopa KP, Basavaiah K. Development and Validation of Spectrophotometric Methods for the Assay of Mirabegron in Bulk and Pharmaceutical Formulation. Journal of applied 2021; 87:1171–1178. https://doi.org/10.1007/s10812-021-01126-2.
  6. Shaik RP, Puttagunta Analytical Method Development and Validation of Solifenacin in Pharmaceutical Dosage Forms by RP-HPLC. ISRN Analytical Chemistry. 2014; 2014: 1-5. https:// doi.org/10.1155/2014/132020.
  7. Teja D, Dasu DC. Quantitative Analysis of Solifenacin Succinate in Pharmaceutical dosage form using UV Absorption Spectroscopy. 2023; Journal of Chemical and Pharmaceutical Sciences. 6(3):195-198.
  8. Srinivasarao Y, Hemant Kumar 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.
  9. Papanna RK, Kanakapura B. Determination of Solifenacin Succinate in Pure and Pharmaceutical Dosage forms by Spectrophotometry. Journal of applied spectroscopy. 2021; 76,1262–1270. https://doi.org/10.1134/S1061934821110101
  10. Abou ElAlamin MM, Toubar SS. Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stabilityindicating assay was BMC Chemistry. 2023; 17(130): 1-18. https://doi.org/10.1186/s13065-023-01043-9
  11. Bhavana V, Kumar HT. RP-HPLC Method for Estimation of Solifenacin Succinate in APT and Tablet Dosage Form. Asian Journal of Pharmaceutical 2019; 9(3): 118-122. http:// dx.doi.org/10.5958/2231-5675.2019.00022.X
  12. Patel J, Patel 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; 2(8): 223-232. https://doi.org/10.47191/ijpbms/ v2-i8-01.
  13. Nadar AM, Boddu Establishment and Validation of Spectrophotometric Method for the Analysis and Quantification of Mirabegron and Solifenacin in Tablet Dosage Forms by Absorption Ratio Method. World Journal of Pharmaceutical Research. 2023; 12(7): 487-503. https://doi.org/10.20959/ wjpr20237-27861.
  14. 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 JPC – Journal of Planar Chromatography – ModernTLC. 2019; 32: 323–327.https://doi.org/10.1556/1006.2019.32.4.7
  15. Kadam MM, Singh Development and Validation of Stability indicating UHPLC Method for the Quantitative Estimation of Mirabegron and Solifenacin Succinate in Pharmaceutical Dosage Form. Journal of Pharmaceutical Negative Results. 2022; 13(07): 6727- 6737. HTTPS://DOI.ORG/10.47750/PNR.2022.13.S07.815
  16. Israel SD, Krishnachaitanya K. Rp-HPLC Method for the Estimation of Tamsulosin and Solifenacin in bulk and its dosage forms. IJPSR. 2013;4(11):43434350.
  17. Geneva: Proceedings of the International Conference on Harmonisation; 1993. Oct, ICH, Q1A, Stability Testing of New Drug Substances and Products.
  18. ICH, Q2A, Hamonised Tripartite Guideline, Test On Validation of Analytical Procedures, IFPMA. In: Proceedings of the International Conference on Harmonization, Geneva, Mar
  19. ICH, Q2B, Hamonised Tripartite Guideline, Test On Validation of Analytical Procedures, IFPMA. In: Proceedings of the International Conference on Harmonization, Geneva, Mar