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METHOD DEVELOPMENT AND VALIDATION FOR DIGESTANT ENZYME BY SPECTROPHOTOMETRIC METHOD

. Balaji Hari, B. Nagesh, P. Sriramcharan and Aman Khandelwal


Abstract

The method developed and validated by using Spectrophotometry for the estimation of pancreatic enzymes in a dosage form. Method: The pancreatic enzyme is dissolved in the Distilled H2O and its absorbance was estimated by using UV-Visible Spectrophotometry. Linearity, Regression equation, Accuracy, Precision, Standard deviation, etc., parameters were calculated and were validated as per ICH guidelines. Results: The maximum concentration of pancreatic enzyme in pure water was 259nm. In the range of concentrations of 100-600g/ml, the drug exhibits linear behaviour, with a correlation coefficient of 0.9996. In order to verify the method's accuracy, three recovery experiments were carried out: one at 50 percent, one at 100 percent, and the third at 150 percent. It was determined that the percentage of recovery was between 99% and 101%. Precision, Accuracy, Repeatability, and Ruggedness were all shown by the method's low percentage of RSD. Conclusion: The above-validated method may be useful for routine analysis of Pancreatic enzyme in a pharmaceutical dosage form.

 

 

Keywords: Pancreatic enzyme, UV-Visible Spectrophotometry.

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