A Comparative Study of Dissolution Profile and Its Validation for Levonorgestrel and Ethinylestradiol Combined Oral Doses Form Tablet

Dissolution is one of the most important characteristics of a drug directly effect on the drug absorption and bioavailability. The dissolution of Levonorgestrel and Ethinylestradiol from oral dosage forms at different dissolution media: Acetate, HCl, Water and Phosphate have been studied by using an RP-HPLC method. Dissolution of Levonorgestrel after 60 min in acetate, HCl, water and phosphate were 98, 95, 97 and 98% respectively. For Ethinylestradiol dissolution after 60 min at indicated media were 91, 82, 92 and 93% respectively. From that point HCl media has been rejected. Difference (f1) and similarity (f2) factor of test sample has been calculated comparing with Microgynon 30 mg Tablet (reference dose) and dissimilarity was found in water and phosphate media and can reject both of them. Only acetate media has been found the best option among four dissolution media for simultaneous determination of Levonorgestrel and Ethinylestradiol COCs. By using acetate buffer a complete analytical dissolution method has been validated accurding to FDA, ICH and USP category 1 requirement. It was found that this method was permeated all validation parameter. This acetate buffer has successfully been used for determination of both active from Levonorgestrel/Ethinylestradiol tablet that was manufactured by five different companies.