Experimental studies of validation and stability of Sweet Bee Venom using HPLC
Objectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods : All experiments were conducted at Biotoxtech, a non...
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| Format: | Article |
| Language: | English |
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Korean Pharmacopuncture Institute
2009-12-01
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| Series: | Journal of Pharmacopuncture |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.3831/KPI.2009.12.4.033 |
| _version_ | 1818250774428254208 |
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| author | Kye Sung, Kang Ki Rok, Kwon |
| author_facet | Kye Sung, Kang Ki Rok, Kwon |
| author_sort | Kye Sung, Kang |
| collection | DOAJ |
| description | Objectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing
protein isolation method of gel filtration.
Methods : All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Standard solutions of melittin (SIGMA, USA) and test substances were dispensed and were analyzed with HPLC for Sweet BV to secure the validation of analysis.
Results :
1. Measurement of system suitability of Sweet BV satisfied criterion of below 3%.
2. Confirming Linearity of Sweet BV in 10-200㎍/㎖ solution yielded correlation coefficient (r) of 0.995 and accuracy of 85-115% which satisfy criterion.
3. Measurement of Specificity of Sweet BV didn't yield any substance affecting the peak of test substances, but detected at 21.22min verified as the test substance.
4. Confirming Intra-day of Sweet BV, accuracy and precision of 0.1, 100㎍/㎖ were 105.70, 95.81 and 0.66, 0.73, respectively, satisfying both criteria of accuracy (85-115%) and precision (within 10%).
5. To measure Stability in autosampler, all samples used in Intra-day reproducibility sat in the autosampler for five hours and were re-analyzed. Both variability and precision satisfied the criteria.
6. Homogeneity of Sweet BV (0.1, 100㎍/㎖) at upper, middle, and lower layers all satisfied the accuracy and precision criteria.
7. Stability of Sweet BV (0.1, 100㎍/㎖) at room temperature for four hours and refrigerated for 7 days all satisfied the criterion.
8. For the measurement of Quality control, QC samples measured on the first and eighth day all satisfied accuracy and precision criteria.
Conclusion : Above experiment data satisfies validation and stability of concentration analysis method of Sweet BV. |
| first_indexed | 2024-12-12T15:57:44Z |
| format | Article |
| id | doaj.art-fcc56da1f67242e681fc84bf5991b978 |
| institution | Directory Open Access Journal |
| issn | 2093-6966 2234-6856 |
| language | English |
| last_indexed | 2024-12-12T15:57:44Z |
| publishDate | 2009-12-01 |
| publisher | Korean Pharmacopuncture Institute |
| record_format | Article |
| series | Journal of Pharmacopuncture |
| spelling | doaj.art-fcc56da1f67242e681fc84bf5991b9782022-12-22T00:19:28ZengKorean Pharmacopuncture InstituteJournal of Pharmacopuncture2093-69662234-68562009-12-01124335010.3831/KPI.2009.12.4.033Experimental studies of validation and stability of Sweet Bee Venom using HPLCKye Sung, Kang0Ki Rok, Kwon1Dept. of Acupuncture & Moxibustion, College of Korean Medicine, Sangji UniversityDept. of Acupuncture & Moxibustion, College of Korean Medicine, Sangji UniversityObjectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods : All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Standard solutions of melittin (SIGMA, USA) and test substances were dispensed and were analyzed with HPLC for Sweet BV to secure the validation of analysis. Results : 1. Measurement of system suitability of Sweet BV satisfied criterion of below 3%. 2. Confirming Linearity of Sweet BV in 10-200㎍/㎖ solution yielded correlation coefficient (r) of 0.995 and accuracy of 85-115% which satisfy criterion. 3. Measurement of Specificity of Sweet BV didn't yield any substance affecting the peak of test substances, but detected at 21.22min verified as the test substance. 4. Confirming Intra-day of Sweet BV, accuracy and precision of 0.1, 100㎍/㎖ were 105.70, 95.81 and 0.66, 0.73, respectively, satisfying both criteria of accuracy (85-115%) and precision (within 10%). 5. To measure Stability in autosampler, all samples used in Intra-day reproducibility sat in the autosampler for five hours and were re-analyzed. Both variability and precision satisfied the criteria. 6. Homogeneity of Sweet BV (0.1, 100㎍/㎖) at upper, middle, and lower layers all satisfied the accuracy and precision criteria. 7. Stability of Sweet BV (0.1, 100㎍/㎖) at room temperature for four hours and refrigerated for 7 days all satisfied the criterion. 8. For the measurement of Quality control, QC samples measured on the first and eighth day all satisfied accuracy and precision criteria. Conclusion : Above experiment data satisfies validation and stability of concentration analysis method of Sweet BV.http://dx.doi.org/10.3831/KPI.2009.12.4.033Sweet Bee VenommelittinvalidationstabilityHPLC |
| spellingShingle | Kye Sung, Kang Ki Rok, Kwon Experimental studies of validation and stability of Sweet Bee Venom using HPLC Journal of Pharmacopuncture Sweet Bee Venom melittin validation stability HPLC |
| title | Experimental studies of validation and stability of Sweet Bee Venom using HPLC |
| title_full | Experimental studies of validation and stability of Sweet Bee Venom using HPLC |
| title_fullStr | Experimental studies of validation and stability of Sweet Bee Venom using HPLC |
| title_full_unstemmed | Experimental studies of validation and stability of Sweet Bee Venom using HPLC |
| title_short | Experimental studies of validation and stability of Sweet Bee Venom using HPLC |
| title_sort | experimental studies of validation and stability of sweet bee venom using hplc |
| topic | Sweet Bee Venom melittin validation stability HPLC |
| url | http://dx.doi.org/10.3831/KPI.2009.12.4.033 |
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