RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF MEBEVERINE HYDROCHLORIDE AND CHLORDIAZEPOXIDE IN CAPSULES

Authors

  • Ramadevi Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • S. Srikanth Vijaya College of Pharmacy
  • A. Ashok Kumar Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Keywords:

RP-HPLC, Mebeverine, Chlordiazepoxide, Method development, Validation

Abstract

Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for simultaneous quantitative estimation of Mebeverine hydrochloride and Chlordiazepoxide in MEVA C capsules and validate as per ICH guidelines.

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 2.5): acetonitrile in the proportion of 60:40 v/v, flow rate of 1.0 ml/min and a detection wavelength of 240 nm using a UV detector.

Results: The developed method resulted in Mebeverine eluting at 5.8 min and Chlordiazepoxide at 3.9 min. Mebeverine exhibited linearity in the range 250-750μg/ml, while Chlordiazepoxide exhibited linearity in the range 9.25-27.75μg/ml. The precision is exemplified by relative standard deviations of 1.45% for Mebeverine and 1.58% for Chlordiazepoxide. Percentage Mean recoveries were found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) for Mebeverine hydrochloride and Chlordiazepoxide were found to be 91.67µg/ml and 2.23µg/ml respectively, while limit of quantitation (LOQ) for Mebeverine hydrochloride and Chlordiazepoxide were found to be 277.81µg/ml and 6.77µg/ml respectively.

Conclusion: A simple, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneous quantitative estimation of Mebeverine hydrochloride and Chlordiazepoxide in MEVA C capsules and validated as per ICH guidelines. Hence it can be used for the routine analysis of Mebeverine and Chlordiazepoxide in capusles in various pharmaceutical industries.

 

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Author Biographies

Ramadevi, Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Department of Pharmaceutical Analysis and Quality assurance

S. Srikanth, Vijaya College of Pharmacy

ANAYTICAL R&D; FORMULATION R&D

A. Ashok Kumar, Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Department of Pharmaceutical Analysis and Quality assurance

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Published

01-02-2015

How to Cite

Ramadevi, S. Srikanth, and A. A. Kumar. “RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF MEBEVERINE HYDROCHLORIDE AND CHLORDIAZEPOXIDE IN CAPSULES”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 2, Feb. 2015, pp. 314-8, https://mail.innovareacademics.in/journals/index.php/ijpps/article/view/2964.

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