Development and Validation of an Analytical Method for the Simultaneous Estimation of Azadirachtin and Camphor in a New Herbal Formulation
Keywords: Azadirachtin, Camphor, Reversed-phase high-performance liquid chromatography, Formulation, Validation.
AbstractBackground: High-performance liquid chromatography (HPLC) is an analytical tool for determining the quality of a drug product. Separating, identifying, and quantifying the various drugs should be able to HPLC methods. To quantify azadirachtin and camphor, a novel HPLC technique was created that is sensitive and selective. Objective: The analysis of azadirachtin and camphor has been designed and verified using a simple, efficient, selective, and precise HPLC technique. Material and Method: With the help of an HPLC C18 column (4.6 x 250 mm, 5 m), a mobile phase made up of buffer (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio 15:85, flow rate of 1.0 mL/min, and column temperature kept at 35°C, good chromatographic separation was achieved in the current study. The resulting effluents were seen at 294 nm using a UV-visible detector. Result and Discussion: Sharp peaks for azadirachtin and camphor were found at retention times of 3.5 and 4.8 minutes, respectively, during the detection process at 294 nm. Over the concentration ranges of 0.1–0.9 g/mL for azadirachtin and 20–180 g/mL for camphor, the calibration curve was linear. According to International Council on Harmonisation (ICH) guidelines, the method was verified for accuracy, precision, repeatability, specificity, robustness, and detection and quantification limits. Conclusion: The proposed method has specificity, accuracy, and sensitivity, with an excellent linear.
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