Abstract
Aim: The paper discusses the Spectrophotometric method developed to determine Cilnidipine in pharmaceutical formulation.
Methodology: The method depends on the reaction of the nitro group of the drug with Potassium Hydroxide in Dimethyl Sulphoxide (DMSO) medium to form a coloured product, which shows maximum absorbance at 425 nm. It also Common excipents used in the formulation bear no effect on the proposed method. The authenticity and performance of the proposed method is approved by point and interval hypothesis tests and through recovery studies.
Results: The linear regression equations obtained by applying least square regression analysis for Cilnidipine were r2= 0.9997 and adheres Beer's Law in the concentration range of 1-9 mu g/ ml.
Conclusion: The method was validated for specificity, linearity, accuracy, precision, Limit of detection and limit of quantification are found to be suitable to be employed in Quality Control as per the International Conference on Harmonization guidelines.