Analytical Method Development And Validation Of Finasteride By Using RP- HPLC

Abstract

In case of  Benign prostatic hyperplasia (BPH) for men with an enlarged prostate, finasteride is used to reduce the size of the prostate potentially prevent surgery. Finasteride tablets are used for the treatment of androgenetic alopecia, or male-pattern hair loss, with the aim to gradually promote hair growth and volume.  High-performance liquid chromatography (RP-HPLC) was utilized to develop a rapid and specific stability indicating technique for finasteride detection. Separation was carried out by using a  Acetonitrile mobile phase consisting of 0.01M Potassium phosphate monohydrate buffer (KH2PO4) pH 3.50 buffer: Acetonitrile in the ratio of 90:10. C18, (150×4.6) mm, 5µm, 1.0 ml/min flow rate, and 25°C temperature were utilized in the column. Finasteride was eluted at approximately 6.5 minutes after the detection, it was performed at 222 nm. Specificity, precision, linearity, accuracy, repeatability, and robustness were all analyzed according with ICH recommendations. It was found that the calibration curves for the concentration ranges of 10–60 ppm were linear. It was found that the drug's typically working curve equation was y = 25126x + 65930, with a correlation value of R² = 0.9864. The method's accuracy and precision are within an acceptable range. The results of the study indicated the validated method's simplicity and accuracy, confirming its efficacy for finasteride measurement.