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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DUTASTERIDE WITH TAMSULOSIN IN PHARMACEUTICAL CAPSULE DOSAGE FORM BY RP-HPLC METHOD

*Priyadarshani S Bansode, Chetan Singh Chauhan, Preeti Gopaliya, Chatrapal singh, Ravindra Kamble, Mahendra Singh Ranawat, Sujata S Bansode

Analytical method development & validation play important roles in the discovery development & manufacture of pharmaceuticals. Reversed phase HPLC (RP-HPLC) has a non-polar stationary phase and an aqueous, moderately polar mobile phase. A mixture of buffer solution and methanol in the ratio of (45:55). Drugs showed maximum absorbance at 280 nm for Dutasteriod and 225 nm for Tamsulosin. The % Accuracy is within limit (98.0 – 102.0 %) with %RSD less than 2%. The Precision RSD of Assay of six sample preparations was found to be 2.0%. The correlation coefficient value should not be less than 0.995 over the working range. The validation was performed as per International Conference on Harmonization (ICH) guidelines.


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