DEVELOPMENT AND VALIDATION OF A UV-VISIBLE SPECTROPHOTOMETER METHOD FOR DETERMINATION OF PRAMLINTIDE IN PHARMACEUTICAL DOSAGE FORM

Background: The objective of my research work is to develop and validate the UV-spectrophotometric method for the estimation of Pramlintide in bulk and pharmaceutical formulations as per ICH guidelines Materials and Methods: A UV-visible spectrophotometric method has been developed using distilled water as solvent. Pramlintide standard solutions (5–25 µg/mL) were prepared and scanned between 200 and 400 nm. Calibration curve, precision, accuracy, Limit of Detection (LOD) and Limit of Quantification (LOQ) were evaluated as per ICH Q2(R2) guidelines. Results: The lmax of Pramlintide in distilled water was found to be 230 nm. The drug follows linearity in the concentration range 5-25 µg/ml with a correlation coefficient value of 0.9847. The precision of the method was studied for an intraday and interday variation. The proposed method was applied to pharmaceutical formulation and percentage amount of drug estimated between 98.66 to 101.5% and was found to be in good agreement with the label claim. The recovery was found to be in the range of 100.68 to 102.13%. The low values of %RSD are indicative of the accuracy and reproducibility of the method. Robustness was evaluated by applying small deliberate changes in wavelength to observe the method’s consistency. Ruggedness assessment across different analysts and days yielded %RSD values below 2, affirming the stability of the method. LOD and LOQ were found to be 1.58 and 5.22 µg/ ml respectively, demonstrating high sensitivity. Conclusion: The above method was a rapid tool for routine analysis of Pramlintide in the bulk and in the pharmaceutical dosage form.