Development And Validation Of Analytical Methods

Two UV-Spectrophotometric and RP-HPLC methods have been developed and validated for estimation of Amlodipine Besilate and Indapamide simultaneously.In absorbance correction method absorbance was measured at 360 nm for Amlodipine Besilate and at 242 nm for Indapamide. In First order Spectrophotometry method, the dA/dλ value in first order derivative spectra was measured at 242 nm for Amlodipine Besilate and 238 nm for Indapamide. The proposed methods were utilized for estimation of Amlodipine Besilate and Indapamide in tablet dosage form. RP-HPLC method showed adequate separation of Amlodipine Besilate and Indapamide. Amlodipine Besilate and Indapamide were estimated on C18 column using Acetonitrile: Water (contains 0.2% of Triethylamine and adjusting the pH to 4.0 with 10 % orthophosphoric acid) in a proportion of 70:30 v/v as mobile phase and detection was carried out at 238 nm. Results of Validation study and assay of all three methods were found to be satisfactory. The developed method were statistically compared using one way ANOVA which suggest that there is no significance difference among all three methods.