Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method
Bibliographic record
Abstract
Flibanserin (Addyi) is a medication used to treat women who have not gone through menopause who have low sexual desire. Specific and simple stability indicating method was developed and validated by high-performance liquid chromatography (RP-HPLC) for the determination of Flibanserin. Separation was carried out by using a mobile phase consisting of 0.01M Potassium phosphate monohydrate buffer (KH2PO4) pH 3.50 buffer: Acetonitrile in the ratio of 60:40. The column used was Agilent C18, (150×4.6) mm, 5µm with a flow rate of 1.0ml/min and temperature at 30°C. The detection was carried out at 248 nm and Flibanserin was eluted at around 2.8min. This method was validated as per ICH guidelines and validation included specificity, precision, linearity, accuracy, forced degradation, and robustness. Forced degradation was conducted under the conditions of hydrolysis, oxidation, thermal, acid, base, and peroxide hydrolysis. The calibration curve was linear over the concentration range from 20 to 200µg/mL and the coefficient of determination (r2) was observed as 0.9998. The precision and accuracy of the method were within the acceptable range. The results of this study showed that the validated method is simple and accurate, which confirmed that the method is suitable for the determination of Flibanserin.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".