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

International Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2024-01-01 DOI:10.22159/ijpps.2024v16i1.49569

Bembadi Mukund Reddy, Bheemi Reddy ASHOK REDDY, U. T. Naidu, Akuthota Ashok Kumar, Rajesh Vooturi

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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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一种简便的 RP-HPLC 方法，用于开发和验证缓释片中的菠萝蛋白酶溶解度--一种复杂的蛋白酶混合物

目的建立一种简便、准确、精密、线性的反相高效液相色谱（RP-HPLC）方法，并验证其对缓释片中菠萝蛋白酶的定量测定（溶出）：经优化的RP-HPLC方法适用于缓释片在酸性和缓冲液阶段的溶出，采用Zorbax 300 SB-C8色谱柱（150 mm X 4.6 mm; 3.5μ），流动相-A为0.1%三氟乙酸水溶液，流动相-B为0.流速 1.0 ml/min，进样量 25 µl，紫外/PDA 检测器检测波长 280 nm，柱温 40 °C，样品盘/样品室温度 5 °C，运行时间 20 min：采用所开发的方法，菠萝蛋白酶的洗脱时间约为 6 分钟。菠萝蛋白酶在 53.4-800.6 μg/ml 范围内呈线性关系（r2=0.99992）。酸性和缓冲液阶段的相对标准偏差分别为 1.3% 和 2.3%，体现了其精密度。在准确度研究中发现，药物的回收率在 90.0 至 110.0 之间：建立并验证了一种简单、准确、精确、线性的 RP-HPLC 方法，用于片剂中菠萝蛋白酶的定量估算（溶出）。

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International Journal of Pharmacy and Pharmaceutical Sciences

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