A Validated Method Development for Quantification of Pravastatin Sodium using Diffuse Reflectance Fourier Transform Spectroscopy

Abstract:

Objective: The plan of the proposed work is development and validation of a new, simple and cost- effective method using Diffuse Reflectance Fourier Transform Infrared Spectroscopy as a method of choice for analysis of Pravastatin in the solid dosage forms. Method: Spectrum using Fourier transform infrared (DRS 8000) was analyzed after preparing solid state sample through diluting in dry potassium bromide. The method was validated according to the International conference on Harmonization guidelines including linearity, accuracy, precision, robustness and selectivity. Results: A linear relationship was found in the selected wave number 1740 -1705 cm-1denoting the hydroxyl peak in the concentration range of 5-30% w/w admitting a good correlation coefficient of 0.9978. The three marketed tablet dosage form selected for the determination of % recovery of Pravastatin was in the range of 97.38-98.14% w/w. The % relative standard deviation for day 1 precision studies of five samples was found in the acceptable range of 0.68–1.83 similarly for day 3 precision studies the range was 0.727–1.379. All the results found for the validation parameters were excellent in the proposed method. Conclusion: The present research work depicts that Diffuse Reflectance Infrared Fourier Transforms has a tremendous potential which can be selected as a method of choice for determination of drug content in Pravastatin.

Key words: Pravastatin Sodium, Validation, Diffuse Reflectance Infrared Fourier Transform Spectroscopy, Fourier Transform Infra Red Spectroscopy, International Conference on Harmonization Guidelines, Method Development.