A SIMPLE RP-HPLC METHOD DEVELOPMENT AND VERIFICATION OF THE DISSOLUTION OF BROMELAIN-A COMPLEX MIXTURE OF PROTEOLYTIC ENZYMES, IN DELAYED-RELEASE TABLETS

BEMBADI MUKUND REDDY; BHEEMI REDDY ASHOK REDDY; UPPULURI TRIVIKRAM NAIDU; AKUTHOTA ASHOK KUMAR; RAJESH VOOTURI

doi:10.22159/ijpps.2024v16i1.49569

Authors

BEMBADI MUKUND REDDY Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
BHEEMI REDDY ASHOK REDDY Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
UPPULURI TRIVIKRAM NAIDU Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
AKUTHOTA ASHOK KUMAR Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
RAJESH VOOTURI Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India

DOI:

https://doi.org/10.22159/ijpps.2024v16i1.49569

Keywords:

RP‐HPLC, Bromelain, Dissolution, Acid and buffer stages, Delayed release tablets, Analytical method development

Abstract

Objective: To develop a simple, accurate, precise and linear Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method and verify for the quantitative estimation (Dissolution) of Bromelain in delayed-release tablets.

Methods: The optimized RP-HPLC method for both acid and buffer stage dissolutions of delayed-release tablets uses Zorbax 300 SB-C8 column (150 mm X 4.6 mm; 3.5μ), a mobile phase-A of 0.1% trifluoroacetic acid in water and a mobile phase-B of 0.1% Trifluoroacetic acid in Acetonitrile in the gradient proportion, flow rate of 1.0 ml/min, injection volume of 25 µl, detection wavelength of 280 nm using a UV/PDA detector, column temperature of 40 °C, sample tray/compartment temperature of 5 °C and a run time of 20 min.

Results: The developed method gave Bromelain eluting at about 6 min. Bromelain exhibited linearity in the range 53.4-800.6 μg/ml (r²=0.99992). The precision is exemplified by relative standard deviation of 1.3 and 2.3% for acid and buffer stages, respectively. Percentage recovery of the drug was found to be between 90.0 and 110.0 during accuracy studies.

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

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