Development and Validation of Rp-Hplc Method ...

Development and Validation of Rp-Hplc Method for Estimation of Dydrogesterone in Tablet Dosage Form

Author Name : Urmi A Vyas, Dr. Sibaji Sarkar, Mr. Dhirendrakumar Tarai

ABSTRACT The optimum wavelength for the determination of Dydrogesterone was selected at 232 nm. Various trials were performed with different mobile phases in different ratios, but Phosphate Buffer(pH4.5): Methanol (25:75) was selected as good peak symmetry. Column is Agilent ZorbaxC18, 250x4.6, 5μ The Retention time of Dydrogesterone was found to be 3.178 min. A new precise, accurate, rapid method has been developed for the simultaneous estimation of Dydrogesterone in pharmaceutical dosage form by RP- HPLC. Method validation done with Linearity range of 4-16 μg/ml. Co-relation coefficients (0.9993). and % Recovery assay of 99.906 ± 0.471to 99.836 ± 0.538, Limit of Detection (LOD) Limit of Quantification (LOQ) of 2.61 μg/ml and 7.91 μg/ml of Dydrogesterone. the proposed method is highly sensitive, precise and accurate and it successfully applied for the quantification of API content in the commercial formulations of Dydrogesterone in Educational institutions and Quality control laboratories. Keyword: RP-HPLC, Dydrogesterone, UV Spectroscopy