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Baku pembanding sangat penting dalam pengawasan obat dan makanan untuk menjamin kualitas dan validitas hasil pengujian. Sesuai dengan ISO 17034:2016, PPPOMN sebagai produsen bahan acuan harus mengevaluasi dan memonitor stabilitas baku pembanding sekunder yang diproduksi. Uji stabilitas merupakan langkah krusial untuk memastikan bahwa kualitas produk tetap terjaga selama penyimpanan dan penggunaan. Namun, baku pembanding yang dikembangkan oleh PPPOMN belum dilakukan uji stabilitas untuk menentukan masa simpan baku pembanding tersebut. Oleh karena itu, pada penelitian ini dilakukan studi stabilitas baku pembanding glukosamin hidroklorida untuk memastikan kestabilannya selama proses transportasi, distribusi, dan penyimpanan. Studi stabilitas jangka panjang dilakukan pada suhu penyimpanan 4-8°C pada 0 bulan sebagai kontrol dan selama 72 dan 144 bulan, studi stabilitas jangka pendek dilakukan pada suhu 25°C dan 60°C pada 0 jam dan selama 72, 120, 168, dan 240 jam. Metode analisis stabilitas dengan KCKT yang tervalidasi. Stabilitas analit dianalisis dengan uji t. Hasil analisis menunjukkan baku pembanding glukosamin hidroklorida stabil pada suhu penyimpanan yang direkomendasikan selama 144 bulan stabil selama distribusi dengan maksimal suhu 60°C selama 240 jam (t hitung = 0,976). Studi membuktikan bahwa baku pembanding Glukosamin hidroklorida stabil pada kondisi penyimpanan tersebut. Dengan demikian, kualitas dan validitas hasil pengujian sediaan farmasi yang menggunakan baku pembanding tersebut dapat terjamin. Dari penelitian ini dapat disimpulkan bahwa baku pembanding Glukosamin hidroklorida memiliki kualitas yang terjamin dan dapat digunakan sepanjang disimpan pada kondisi penyimpanan dan umur simpan yang direkomendasikan. Informasi terkait kondisi penyimpanan dan umur simpan dapat dicantumkan pada label baku pembanding tersebut.
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Referensi
- Ahuja, S. (2005). Overview: Handbook of Pharmaceutical Analysis by HPLC. In Separation Science and Technology (Vol. 6, Issue C). https://doi.org/10.1016/S0149-6395(05)80045-5
- Alberto-Silva, C., Malheiros, F. B. M., & Querobino, S. M. (2020). Fourier-transformed infrared spectroscopy, physicochemical and biochemical properties of chondroitin sulfate and glucosamine as supporting information on quality control of raw materials. Future Journal of Pharmaceutical Sciences, 6(1). https://doi.org/10.1186/s43094-020-00120-3
- AOAC. (2002). AOAC Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals. AOAC International.
- Ashutosh Kumar Yadav, Abhishek Yadav, Manish Yadav, Md Akhlak, Shweta Mishra, & Jitendra Kumar Rai. (2023). A review on drug stability. International Journal of Science and Research Archive, 9(1), 474–485. https://doi.org/10.30574/ijsra.2023.9.1.0424
- Asthana, C., Peterson, G. M., Shastri, M., & Patel, R. P. (2019). Development and validation of a novel high performance liquid chromatography-coupled with Corona charged aerosol detector method for quantification of glucosamine in dietary supplements. PLoS ONE, 14(5), 1–20. https://doi.org/10.1371/JOURNAL.PONE.0216050
- Carstensen, J., & Rhodes, C. (2007). Drug Stability, Revised, and Expanded: Principles and Practices (3rd ed.). CRC Press:Taylor & Francis Group. https://doi.org/10.1201/9780367801298
- Chauhan, K., & Choudhari, V. (2018). Development and Validation of Stability indicating HPTLC Method for Estimation of Carbocisteine and Amoxicillin as Bulk Drug and in Drug Formulation by Derivatization. International Journal of PharmTech Research, 11(2), 108–118. https://doi.org/10.20902/ijptr.2018.11202
- Choezom, L., Chandan, R. S., & Bannimath, G. (2021). A Green Analytical Method for the Determination of Glucosamine using FTIR Spectrophotometry. Journal of Applied Pharmaceutical Science, 11(6), 125–131. https://doi.org/10.7324/JAPS.2021.110615
- FDA. (2003). Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products, U.S. Department of Health and Human Services, Food and Drug Administration. Substance, Revision 2, 1–22.
- ICH. (2005). Validation of Analytical Procedures : Text and Methodology Q2 (R1). ICH Harmon Tripart Guide, 1–13. https://doi.org/10.1002/9781118532331.ch23
- ISO. (2017). ISO Guide 35 : Reference materials — Guidance for characterization and assessment of homogeneity and stability.
- ISO. (2016). ISO 17034:2016 General requirements for the competence of reference material producers (Vol. 2016).
- Kompantsev, D. V. (2012). Stability of glucosamine dosage forms. Russian Journal of General Chemistry, 82(3), 579–585. https://doi.org/10.1134/S1070363212030371
- Linsinger, T. P. J., Pauwels, J., Van Der Veen, A. M. H., Schimmel, H., & Lamberty, A. (2001). Homogeneity and stability of reference materials. Accreditation and Quality Assurance, 6(1), 20–25. https://doi.org/10.1007/s007690000261
- Pan, Z., Wang, Y., Xie, Y., Tan, J., Zhang, Q., Lu, J., Du, S., & Xue, F. (2023). Solubility and Crystallization of Glucosamine Hydrochloride in Water with the Presence of Additives. Crystals, 13(9). https://doi.org/10.3390/cryst13091326
- United States Pharmacopeia. (2023). Dietary Supplement Monographs, Glucosamine Hydrochloride (USP43-NF38 ed.). United States Pharmacopeia.
- United States Pharmacopoeia. (2024). USP. https://store.usp.org/product/1294207, Retrieved October 17, 2024.
- WHO. (2007). WHO committee on specifications for pharmaceutical preparations, Annex 3, general guidelines for the establishment, maintenance, and distribution of chemical reference standards.
- WHO. (2018). WHO TRS 1010 Annex 10 WHO Guidelines for Stability Testing of Pharmaceutical Products. http://www.who.int/medicines/areas/quality_safety/quality_assurance/.
- Zothanpuii, Ravindran, R., & Kanthiah, S. (2020). a review on Stability Testing Guidelines of Pharmaceutical Products. Asian J. Phar, Clin Res, 13(10), 3–9. https://doi.org/10.22159/ajpcr.2020.v13i10.3884.
Referensi
Ahuja, S. (2005). Overview: Handbook of Pharmaceutical Analysis by HPLC. In Separation Science and Technology (Vol. 6, Issue C). https://doi.org/10.1016/S0149-6395(05)80045-5
Alberto-Silva, C., Malheiros, F. B. M., & Querobino, S. M. (2020). Fourier-transformed infrared spectroscopy, physicochemical and biochemical properties of chondroitin sulfate and glucosamine as supporting information on quality control of raw materials. Future Journal of Pharmaceutical Sciences, 6(1). https://doi.org/10.1186/s43094-020-00120-3
AOAC. (2002). AOAC Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals. AOAC International.
Ashutosh Kumar Yadav, Abhishek Yadav, Manish Yadav, Md Akhlak, Shweta Mishra, & Jitendra Kumar Rai. (2023). A review on drug stability. International Journal of Science and Research Archive, 9(1), 474–485. https://doi.org/10.30574/ijsra.2023.9.1.0424
Asthana, C., Peterson, G. M., Shastri, M., & Patel, R. P. (2019). Development and validation of a novel high performance liquid chromatography-coupled with Corona charged aerosol detector method for quantification of glucosamine in dietary supplements. PLoS ONE, 14(5), 1–20. https://doi.org/10.1371/JOURNAL.PONE.0216050
Carstensen, J., & Rhodes, C. (2007). Drug Stability, Revised, and Expanded: Principles and Practices (3rd ed.). CRC Press:Taylor & Francis Group. https://doi.org/10.1201/9780367801298
Chauhan, K., & Choudhari, V. (2018). Development and Validation of Stability indicating HPTLC Method for Estimation of Carbocisteine and Amoxicillin as Bulk Drug and in Drug Formulation by Derivatization. International Journal of PharmTech Research, 11(2), 108–118. https://doi.org/10.20902/ijptr.2018.11202
Choezom, L., Chandan, R. S., & Bannimath, G. (2021). A Green Analytical Method for the Determination of Glucosamine using FTIR Spectrophotometry. Journal of Applied Pharmaceutical Science, 11(6), 125–131. https://doi.org/10.7324/JAPS.2021.110615
FDA. (2003). Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products, U.S. Department of Health and Human Services, Food and Drug Administration. Substance, Revision 2, 1–22.
ICH. (2005). Validation of Analytical Procedures : Text and Methodology Q2 (R1). ICH Harmon Tripart Guide, 1–13. https://doi.org/10.1002/9781118532331.ch23
ISO. (2017). ISO Guide 35 : Reference materials — Guidance for characterization and assessment of homogeneity and stability.
ISO. (2016). ISO 17034:2016 General requirements for the competence of reference material producers (Vol. 2016).
Kompantsev, D. V. (2012). Stability of glucosamine dosage forms. Russian Journal of General Chemistry, 82(3), 579–585. https://doi.org/10.1134/S1070363212030371
Linsinger, T. P. J., Pauwels, J., Van Der Veen, A. M. H., Schimmel, H., & Lamberty, A. (2001). Homogeneity and stability of reference materials. Accreditation and Quality Assurance, 6(1), 20–25. https://doi.org/10.1007/s007690000261
Pan, Z., Wang, Y., Xie, Y., Tan, J., Zhang, Q., Lu, J., Du, S., & Xue, F. (2023). Solubility and Crystallization of Glucosamine Hydrochloride in Water with the Presence of Additives. Crystals, 13(9). https://doi.org/10.3390/cryst13091326
United States Pharmacopeia. (2023). Dietary Supplement Monographs, Glucosamine Hydrochloride (USP43-NF38 ed.). United States Pharmacopeia.
United States Pharmacopoeia. (2024). USP. https://store.usp.org/product/1294207, Retrieved October 17, 2024.
WHO. (2007). WHO committee on specifications for pharmaceutical preparations, Annex 3, general guidelines for the establishment, maintenance, and distribution of chemical reference standards.
WHO. (2018). WHO TRS 1010 Annex 10 WHO Guidelines for Stability Testing of Pharmaceutical Products. http://www.who.int/medicines/areas/quality_safety/quality_assurance/.
Zothanpuii, Ravindran, R., & Kanthiah, S. (2020). a review on Stability Testing Guidelines of Pharmaceutical Products. Asian J. Phar, Clin Res, 13(10), 3–9. https://doi.org/10.22159/ajpcr.2020.v13i10.3884.