A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF SOLIFENACIN SUCCINATE IN TABLETS

  • Chandra Mohan Thota Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • Hemalatha Rathod Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • Shainy Botumanchi Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • Vasundhara Gaddam Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • Sandhya Rani Boddapati Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • Ashok Kumar Akuthota Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Abstract

Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Solifenacin succinate (5mg) in tablets.

Methods: The optimized method uses a reverse phase column, Enable Make C18G (250 X 4.6 mm; 5μ), a mobile phase of triethylammonium phosphate buffer (pH 3.5): acetonitrile in the proportion of 30:70 v/v, flow rate of 1.0 ml/min and a detection wavelength of 210 nm using a UV detector.

Results: The developed method resulted in Solifenacin succinate eluting at 3.5 min. Solifenacin succinate exhibited linearity in the range 10-30μg/ml. The precision is exemplified by relative standard deviation of 0.76%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 7.65μg/ml and 23.19μg/ml respectively.

Conclusion: A rapid, accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of solifenacin succinate in SOLITEN (5mg) tablets as per ICH guidelines and hence it can be used for routine analysis in various pharmaceutical industries.

 

Keywords: RP‐HPLC, Solifenacin succinate, Method development, Validation.

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Author Biographies

Chandra Mohan Thota, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
Department of Pharmaceutical Analysis and Quality assurance
Hemalatha Rathod, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
Department of Pharmaceutical Analysis and Quality assurance
Shainy Botumanchi, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
Department of Pharmaceutical Analysis and Quality assurance
Vasundhara Gaddam, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
Department of Pharmaceutical Analysis and Quality assurance
Sandhya Rani Boddapati, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
Department of Pharmaceutical Analysis and Quality assurance
Ashok Kumar Akuthota, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
Department of Pharmaceutical Analysis and Quality assurance

References

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How to Cite
Thota, C. M., H. Rathod, S. Botumanchi, V. Gaddam, S. R. Boddapati, and A. K. Akuthota. “A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF SOLIFENACIN SUCCINATE IN TABLETS”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 6, no. 10, 1, pp. 201-4, https://innovareacademics.in/journals/index.php/ijpps/article/view/2160.
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