Determination of Berberine Hydrochloride in Weikangning Tablets by UV-1500PC Ultraviolet Spectrophotometry - Master's thesis - Dissertation

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Determination of Berberine Hydrochloride in Weikangning Tablets Using UV-1500PC Ultraviolet Spectrophotometry

Key words: ultraviolet spectrophotometry; content of berberine hydrochloride in Weikangning tablets; US analysis

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        <p>Abstract: This study presents a reliable and efficient method for determining the concentration of berberine hydrochloride in Weikangning tablets using UV-1500PC ultraviolet spectrophotometry. The method involves measuring absorbance at 375 nm with 0.05 mol/L sulfuric acid as the reference solution. The results show that the compound exhibits a strong linear relationship within the range of 4–28 mg/L, with a correlation coefficient of r=0.9999. The average recovery was 99.55% (n=5), and the RSD was 0.36%. This technique is simple, accurate, and suitable for quality control in pharmaceutical production.</p>

        <p>ABSTRACT: The objective of this study was to develop a precise and practical method for determining the content of berberine hydrochloride in Weikangning tablets using UV spectrophotometry. The method was validated by measuring absorbance at 375 nm, with 0.05 mol/L sulfuric acid as the reference solution. The calibration curve showed a linear relationship between 4 and 28 mg/L (r=0.9999). The average recovery was 99.55%, with an RSD of 0.36%. The method proved to be simple, accurate, and reproducible, making it ideal for rapid analysis in production settings.</p>

        <p>Weikangning tablets are commonly used for treating peptic ulcers, and their effectiveness has been well-documented. Berberine hydrochloride is the main active ingredient, and its content is typically determined using redox methods outlined in the second part of the Chinese Pharmacopoeia. However, these methods can be time-consuming and complex. In this paper, we present an alternative approach using UV spectrophotometry, which is more straightforward and efficient for quality control purposes.</p>

        <p>1. Instruments and Reagents: UV-1500PC ultraviolet spectrophotometer, electronic balance, sulfuric acid, anhydrous ethanol, berberine hydrochloride reference substance (from the National Institute for the Control of Pharmaceutical and Biological Products), and Weikangning tablets (each containing 0.15 g of berberine hydrochloride and 0.05 g of sucralfate).</p>

        <p>2. Method and Results:</p>
        <p>2.1 Selection of Determination Wavelength: A sample of 25 mg of berberine hydrochloride was dissolved in absolute ethanol and filtered. The solution was diluted to 100 mL and further diluted to 50 mL with 0.05 mol/L sulfuric acid. Absorption spectra were recorded between 200–450 nm. The maximum absorption was observed at 375 nm, making it the optimal wavelength for measurement.</p>

        <p>2.2 Standard Curve Preparation: Solutions of varying concentrations (4–28 mg/L) were prepared, and their absorbance was measured at 375 nm. A linear regression analysis yielded the equation C = 0.0139A + 0.0071, with r=0.9999, confirming a strong correlation between concentration and absorbance.</p>

        <p>2.3 Stability: The control solution remained stable over 2, 4, and 6 months when stored at room temperature. No significant changes in absorbance were observed after 24 hours.</p>

        <p>2.4 Recovery Rate: The average recovery was found to be 99.55% with an RSD of 0.36% (n=5), indicating high accuracy and precision.</p>

        <p>2.5 Effect of Excipients: The presence of starch and methylol starch did not interfere with the determination, as no absorption was detected in the 260–450 nm range.</p>

        <p>2.6 Sample Content Determination: Five batches of Weikangning tablets were analyzed. After grinding and dissolution, the samples were diluted and measured at 375 nm. The results confirmed the reliability of the method for routine quality control.</p>

        <p>Key words: UV spectrophotometry; content of berberine hydrochloride in Weikangning tablets</p>
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