Development of Analytical Method for Boric Acid in the Preparation Using Xtimate Sugar-Ca and Ultisil AQ-C18
Sample Information | |||
|---|---|---|---|
| Sample Name | Eye Drops | Project Number | 20240731-728 |
| Sample Batch Number | / | Sample Characteristics | / |
| Sample Receipt Date | 08/02/2024 | Testing Period | 08/15/2024 ~ 08/16/2024 |
Standard Sample Information | ||
|---|---|---|
| Name | Specification | Quantity |
| Boric Acid | 200 mg | 1 |
| Preparation | 5 ml | 1 |
Requirement | ||
| Develop an analytical method for boric acid in the preparation, ensuring the target substance is not interfered with by other substances. | ||
Experimental Process
Chromatographic Condition 1
| Column |
Xtimate Sugar-Ca (7.8×150mm, 8μm) |
|
|---|---|---|
| Mobile Phase | Pure Water | |
| Flow Rate | 0.5 ml/min | |
| Injection Volume | 20 μL | |
| Column Temperature | 85°C | |
| Detector | Refractive Index Detector | |
| Detector Temperature | 40°C | |
| Elution Program | Time (min) | Pure Water |
| 0 | 100% | |
| 25 | 100% | |
| Precautions | / | |
Chromatographic Condition 2
| Column |
Ultisil AQ-C18 (4.6×250mm, 5μm) |
|
|---|---|---|
| Mobile Phase | Pure Water | |
| Flow Rate | 0.8 ml/min | |
| Injection Volume | 20 μL | |
| Column Temperature | 35°C | |
| Detector | Refractive Index Detector | |
| Detector Temperature | 40°C | |
| Elution Program | Time (min) | Pure Water |
| 0 | 100% | |
| 25 | 100% | |
| Precautions | / | |
Solution Preparation
Mobile Phase Preparation:
Use Wahaha pure water directly.
Standard Solution Preparation:
Solvent: Mobile Phase
Boric Acid Standard Solution: Weigh 100mg of boric acid standard and dissolve in a 5ml volumetric flask with the solvent, mix well until fully dissolved.
Preparation Solution: Provided by the client, ready for direct analysis.
Chromatograms and Data
1) AQ-C18 blank water analysis chromatogram
| Peak Number | Compound | Retention Time (min) | Area | Area % | NTP (USP) | Tailing Factor | Resolution (USP) |
|---|---|---|---|---|---|---|---|
| Total |
2) Xtimate Sugar-Ca column analysis of boric acid standard solution chromatogram
| Peak Number | Compound | Retention Time (min) | Area | Area % | NTP (USP) | Tailing Factor | Resolution (USP) |
|---|---|---|---|---|---|---|---|
| 1 | Boric Acid |
7.17 | 1420241 | 100.00 | 1761 | 1.34 | |
| Total | 1420241 | 100.00 |
3) Xtimate Sugar-Ca column analysis of preparation solution chromatogram
| Peak Number | Compound | Retention Time (min) | Area | Area % | NTP (USP) | Tailing Factor | Resolution (USP) |
|---|---|---|---|---|---|---|---|
| 1 | 3.86 | 156457 | 9.37 | 79 | -- | -- | |
| 2 | 4.91 | 44168 | 2.64 | 484 | -- | 0.8 | |
| 3 | Boric Acid | 7.17 | 1455859 | 87.17 | 1690 | 1.40 | 2.8 |
| 4 | 9.72 | 13667 | 0.82 | 2440 | 1.04 | 3.4 | |
| Total | 1670151 | 100.00 |
4) Ultisil AQ-C18 column analysis of boric acid standard solution chromatogram
| Peak Number | Compound | Retention Time (min) | Area | Area % | NTP (USP) | Tailing Factor | Resolution (USP) |
|---|---|---|---|---|---|---|---|
| 1 | Boric Acid | 6.71 | 1381785 |
100.00 | 7807 | 1.43 | |
| Total | 1381785 |
100.00 |
5) Ultisil AQ-C18 column analysis of preparation solution full-range chromatogram
| Peak Number | Compound | Retention Time (min) | Area | Area % | NTP (USP) | Tailing Factor | Resolution (USP) |
|---|---|---|---|---|---|---|---|
| 1 | 4.23 | 2601 | 0.18 | 639 | 0.76 | -- | |
| 2 | 5.12 | 1054 | 0.07 | 5380 | 1.16 | 1.9 | |
| 3 | Boric Acid | 6.72 | 1406794 | 99.51 | 7725 | 1.41 | 5.5 |
| 4 | 8.16 | 3297 | 0.23 | 10107 | 1.21 | 4.6 | |
| Total | 1413747 | 100.00 |
6) Ultisil AQ-C18 column analysis of preparation solution chromatogram (zoomed-in)
| Peak Number | Compound | Retention Time (min) | Area | Area % | NTP (USP) | Tailing Factor | Resolution (USP) |
|---|---|---|---|---|---|---|---|
| 1 | 4.23 | 2601 | 0.18 | 639 | 0.76 | -- | |
| 2 | 5.12 | 1054 | 0.07 | 5380 | 1.16 | 1.9 | |
| 3 | Boric Acid | 6.72 | 1406794 | 99.51 | 7725 | 1.41 | 5.5 |
| 4 | 8.16 | 3297 | 0.23 | 10107 | 1.21 | 4.6 | |
| Total | 1413747 | 100.00 |
Conclusion
Using the Welch Xtimate Sugar-Ca (7.8×150mm, 8μm) and Ultisil AQ-C18 (4.6×250mm, 5μm) columns, the analysis of boric acid in the preparation was performed under their respective chromatographic conditions. The target substance in the preparation was not interfered with by other substances, meeting the analytical requirements.
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