A SIMPLE RP-HPLC METHOD DEVELOPMENT AND VERIFICATION FOR THE QUANTITATIVE ESTIMATION OF SODIUM BUTYRATE IN TABLETS

BEMBADI MUKUND REDDY; BHEEMI REDDY ASHOK REDDY; AKUTHOTA ASHOK KUMAR; RAVINDER KODIPYAKA; RAJESH VOOTURI

doi:10.22159/ajpcr.2024.v17i3.49574

Authors

BEMBADI MUKUND REDDY Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.
BHEEMI REDDY ASHOK REDDY Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.
AKUTHOTA ASHOK KUMAR Jawaharlal Nehru technological University, Hyderabad (JNTUH)
RAVINDER KODIPYAKA Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.
RAJESH VOOTURI Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.

DOI:

https://doi.org/10.22159/ajpcr.2024.v17i3.49574

Keywords:

RP‐HPLC, Sodium butyrate, Analytical method development, Tablets

Abstract

Objective: To develop a simple, accurate, precise, and linear reverse-phase high-performance liquid chromatographic (RP-HPLC) method and verify the quantitative estimation (assay) of sodium butyrate in tablets.

Methods: The optimized RP-HPLC method uses a reverse phase stationary phase which is YMC Triart C18 column, having specifications of 250×4.6 mm; 5 μm, a mobile phase composition of pH 8.0 sodium dihydrogen phosphate buffer and acetonitrile in the proportion of 92:8 v/v, flow rate of 0.5 ml/min, injection volume of 10 μL, and detection wavelength of 210 nm using a UV/PDA detector.

Results: The developed method gave sodium butyrate eluting at about 6 min. Sodium butyrate exhibited linearity in the range of 119.56–1195.6 μg/ ml. The precision was exemplified by a relative standard deviation of 0.30%. The percentage of individual recovery was found to be in the range of 97.0 and 103.0 during accuracy studies.

Conclusion: A simple, specific, accurate, precise, and linear RP-HPLC method was developed and verified for the quantitative estimation (assay) of sodium butyrate in tablets and hence this method can be explored for the analysis of sodium butyrate in tablets in various pharmaceutical industries.

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Author Biographies

BEMBADI MUKUND REDDY, Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.

B. Mukund Reddy is an analytical scientist with more than 8 years of research experience in various pahrma industries

BHEEMI REDDY ASHOK REDDY, Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.

Ashok Reddy is an anlytical scientist with more than 8 years of research experience in various pharma industries.

AKUTHOTA ASHOK KUMAR, Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Team Leader-Formaulation AR&D,

Aurigene Pharmaceutical Services Limited,

J.P Nagar, Miyapur, Hyderabad-Telanagana-500049 (Pin)

RAVINDER KODIPYAKA, Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.

Ravinder Kodipyaka was the Head, Formulation R&D, having more than 25 years of research experience in various pharmaceutical industries.

RAJESH VOOTURI, Formulation AR&D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India.

Dr. Rajesh is the Head, Formulation R&D, with more than 15 years of research experience in various pahrma industries

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