UV- Method Development for Quantifying 3-Acetyl-11-Keto-Beta-Boswellic Acid in Bulk and Topical Nanoformulation

Purpose: The study aims to present a swift, precise, and sensitive UV-spectrophotometric technique for assessing AKBA in bulk and nanoformulations. Method: The ideal conditions for AKBA analysis was developed using methanol and water in 1:1 ratio. It shows maximum absorbance at 255nm wavelength. Several validation criteria’s such as precision, LOD, LOQ, accuracy, robustness, and ruggedness were estimated with the QC norms in accordance with the ICH Q2 (R1) guidelines. The validated method was used in quantifying AKBA in bulk and nanoformulations. Result: AKBA exhibited a maximum absorption wavelength at 255nm. The linear equation y = 0.012x+0.0196 was established, demonstrating a linear response within the concentration range of 20-60µg/mL with a regression coefficient of 0.995. The limit of detection and limit of quantification were found to be 3.297 and 9.992µg/mL, respectively. The precision and repeatability values were within 2% acceptance range. Following ICH guidelines, the method underwent comprehensive validation for linearity, ruggedness, precision, specificity, and sensitivity, meeting acceptable criteria. Conclusion: Therefore, as per the results, it can be concluded that the developed method is deemed new, simple, consistent, and accurate, suitable for routine quality control in the pharmaceutical industry for raw materials and formulations. 3-acetyl-11-keto-beta-Boswellic acid (AKBA), UV-Spectrophotometric, Nanoformulation, Method development, Estimation.