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


Chandra Mohan Thota, Hemalatha Rathod, Shainy Botumanchi, Vasundhara Gaddam, Sandhya Rani Boddapati, Ashok Kumar Akuthota

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 98‐102, 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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References


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About this article

Title

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

Keywords

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

Date

01-11-2014

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 6, Issue 10, 2014 Page: 201-204

Online ISSN

0975-1491

Statistics

387 Views | 107 Downloads

Authors & Affiliations

Chandra Mohan Thota
Jawaharlal Nehru technological University, Hyderabad (JNTUH)
India

Hemalatha Rathod
Jawaharlal Nehru technological University, Hyderabad (JNTUH)
India

Shainy Botumanchi
Jawaharlal Nehru technological University, Hyderabad (JNTUH)
India

Vasundhara Gaddam
Jawaharlal Nehru technological University, Hyderabad (JNTUH)
India

Sandhya Rani Boddapati
Jawaharlal Nehru technological University, Hyderabad (JNTUH)
India

Ashok Kumar Akuthota
Jawaharlal Nehru technological University, Hyderabad (JNTUH)
India


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