A VALIDATED RPHPLC METHOD FOR THE DETERMINATION OF IMPURITIES IN TAMSULOSIN HCL
Bibliographic record
Abstract
A simple and rapid reversed phase high performance liquid chromatographic method for the separation and determination of process related impurities of Tamsulosin HCL (TAM) was developed. The separation was achieved on a reverse phase C18 column using the gradient LC method, solution A and solution B as mobile phase. The solution A contains aqueous ortho phosphate buffer pH 6.5 and solution B contains a mixture of water: acetronitrile (90:10%v/v). The method was linear over a range of 0.2 to 1.9µg/ml for process related impurities and 0.2 to 12.8µg/ml for Tamsulosin HCL. The recoveries were found to be in the range of 92.14 to 104.44% for impurities as well as Tamsulosin HCL. The precision and robustness of the method were evaluated. It was subjected to the stress condition of oxidative, acidic, basic, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from the main peak and its impurities, proving the stability indicating power of the method. It was used not only for quality assurance, but also for monitoring the synthetic reaction involved in the process development work in the laboratory. The method was found to be specific, precise and reliable for the determination of un reacted levels of raw materials, intermediates in the reaction mixtures and the finished products of Tamsulosin HCL.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".