TABLETLERDE GLİKLAZİT MİKTAR TAYİNİ İÇİN SPEKTROFOTOMETRİK YÖNTEM GELİŞTİRME VE DOĞRULAMA

Amaç: Dozaj formlarında gliklazid miktar tayini için yeni bir spektrofotometrik yöntem geliştirilmiştir.Gereç ve Yöntem: Gliklazidin oda sıcaklığında aseton ortamında bromokresol yeşili ile reaksiyona girerek 411 nm'de maksimum absorpsiyona sahip sarı bir ürün oluşturduğu deneysel olarak belirlenmiştir. Kimyasal ajanın optimal konsantrasyonu belirlendi ve araştırılan çözeltilerin stabilitesi, 30 dakika boyunca optik yoğunlukları ölçülerek kontrol edildi ve 62.00 - 94.00 mg/100 ml aralığında Beer yasasına uygun olduğu görüldü. Tespit limiti, reaksiyonun yüksek hassasiyetini gösteren 4.02~10-6 g/ml'dir. Önerilen yöntem, Ukrayna Devlet Farmakopesi gerekliliklerine göre doğrulanmıştır.Sonuç ve Tartışma: Çalışmanın sonuçları, geliştirilen yöntemin uygulamasının basit ve ekonomik olduğunu ve dozaj formlarının kalite kontrolü için laboratuvarlarda ilaçlarda gliklazidin belirlenmesinde kullanılabileceğini göstermektedir.

Anahtar Kelimeler:

Вromokresol yeşili, gliklazid, spektrofotometri

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR GLICLAZIDE QUANTITATION IN TABLETS

Objective: A new spectrophotometric method for the gliclazide quantitation in dosage forms has been developedMaterial and Method: The subjects of the study were modified-release tablets ("Diaglizide" 80 mg, "Diaglizide MR" 60 mg, "Diaglizide MR" 30 mg, "Diabeton" MR 60 mg, "Gliklada" 60 mg). As a reagent, bromocresol green in acetone was used. Analytical equipment: spectrophotometer Specord 200, electronic scales АВТ-120-5DM.Result and Discussion: It has been experimentally determined that gliclazide reacts with bromocresol green in acetone medium at room temperature to form a yellow product with maximum absorption at 411 nm. The method was validated for linearity, accuracy, precision, and robustness. The agent’s optimal concentration was established and the stability of the investigated solutions was checked by measuring their optical density for 30 minutes. Subordination of Beer's law is observed in the range of 62.00 - 94.00 mg/100 ml. The limit of detection is 4.02∙10-6 g/ml, which indicates a high sensitivity of the reaction. The proposed method is validated according to the requirements of the State Pharmacopoeia of Ukraine. The results of the study show that the developed method is simple and affordable to implement and can be used to determine gliclazide in drugs in laboratories for quality control of dosage forms.

Keywords:

Вromocresol green, gliclazide, spectrophotometry.,

PDF

___

1. International Diabetes Federation. (2019). IDF Diabetes Atlas 9th Edition 2019. Retrieved June 6, 2022, from https://diabetesatlas.org/atlas/ninth-edition/
2. Сompendium online directory of medicines Web site. (2022) Date added: 03.05.2022 https://compendium.com.ua/dec/266948/ 3. Wang, C. Y., Zhang, W., Xiang, B. R., Yu, L. Y., Ma, P. C. (2008). Liquid chromatography–mass spectrometry method for the determination of gliclazide in human plasma and application to a pharmacokinetic study of gliclazide sustained release tablets. Arzneimittel Forschung, 58(12), 653-658. [CrossRef]
4. Kumar, B. V. V., Patnaik, A. K., Raul, S. K., Rao, N. N. (2013). A RP-HPLC method development and validation for the estimation of gliclazide in bulk and pharmaceutical dosage forms. Journal of Applied Pharmaceutical Science, 3(4), 59-62. [CrossRef]
5. Gandhimathi, M., Anandakumar, K., Cheriyan, A., Ravi, T.K.. (2003). Simultaneous estimation of Metformin and gliclazide in tablet using reverse phase high performance liquid chromatography. Indian Journal of Pharmaceutical Sciences. 65, 530-531.
6. Krzek, J., Czekaj, J., Moniczewska, M., Rzeszutko, W. (2001). Determination of Gliclazide in Pharmaceutical Preparations by Capillary Gas Chromatography with Cool On-Column Injection and Elimination of the Matrix Effect. Journal of AOAC Internatıonal, 84(6), 1695-1702. [CrossRef]
7. Bhattacharya, K., Mathew, J. (2021). Development and validation of stability-indicating UPLC method for the determination of gliclazide and its impurities in pharmaceutical dosage forms. Futur Journal of Pharmaceutical Sciences, 7, 95. [CrossRef]
8. Wang, X., Zhang, C. (2022) Determination of Gliclazide in Dameikang Tablets by Internal Standard Method of Nuclear Magnetic Resonance[J]. Experiment Science and Technology, 20(3), 7-10. [CrossRef]
9. Reichal, C.R., Rao, M.G. (2015). Development and validation of spectrophotometric method for simultaneous estimation of gliclazide and sitagliptin phosphate monohydrate in bulk and pharmaceutical dosage form. International Journal of Pharmacy and Pharmaceutical Sciences, 7. 372-376.
10. Samina, A. J., Snehal, P. M., Poonam, S. K., Yogesh, V. P., Kishor, B. B. (2011). Development and validation of UV spectrophotometric method for the determination of Gliclazide in tablet dosage form. Der Pharma Chemica, 3(4), 338-343. [CrossRef]
11. Saroj, R., Bukkuru, S., Patibandla, S., Vegiraju, V. (2016). UV Spectrophotometric Method Development and Validation for the Estimation of Gliclazide in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis, 6(3) 143-146. [CrossRef]
12. Jeha, B., Salami, M. (2019). Spectrophotometric Determination of Gliclazide in Bulk and Pharmaceutical Formulation using 1, 2-naphthoquinone-4-sulfonic acid Sodium salt. Research Journal of Pharmacy and Technology, 12(11), 5310-5314. [CrossRef]
13. Doomkaew, A., Prutthiwanasan, B., Suntornsuk, L. (2015) Stability indicating MEKC method for the determination of gliclazide and its specified impurities. Journal of Pharmaceutical and Biomedical Analysis, 102, 119-128. [CrossRef]
14. Pharmacopoeia of Ukraine, D. (2015). SE "Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines". 2nd type. Kharkiv: SE "Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, 1, 1148 p.
15. Grizodub, A.I. (2016). Standardization of the procedure for validation of methods of quality control of drugs. (pp 64-67). Kharkiv: State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Drug Quality".