Author(s): Kucherenko Liudmyla, Nimenko Hanna, Khromylova Olga, Borsuk Serhii, Belenichev Igor, Hura Elina

Email(s): borsuksergejjj@gmail.com

DOI: 10.52711/0974-360X.2023.00721   

Address: Kucherenko Liudmyla, Nimenko Hanna, Khromylova Olga, Borsuk Serhii, Belenichev Igor, Hura Elina
Department of Pharmaceutical, Organic and Bioorganic Chemistry and Department of Pharmacology and Medical Prescription with a course of normal Physiology, Zaporizhzhia State Medical University, The city of Zaporizhzhia, Ukraine.
*Corresponding Author

Published In:   Volume - 16,      Issue - 9,     Year - 2023


ABSTRACT:
The discovery of recent decades has established that the majority of widespread human diseases that reduce life expectancy and reduce social activity, especially pathology of the cardiovascular system, respiratory tract, neurodegenerative diseases, and malignant neoplasms have a clearly expressed free-radical phase in their pathogenesis. It is important to create medicines based on fixed combinations containing compatible physico-chemical and pharmacological characteristics of an antioxidant and a drug of basic therapy, which determines their higher therapeutic efficiency and safety compared to the use of individual components of complex treatment. The most promising antioxidant component of fixed combinations is thiotriazoline. The creation of highly effective medicinal products based on fixed combinations with antioxidant, thiotriazoline allows not only to enhance the main properties of the basic component (nootropic, neuroprotective, anticonvulsant, anti-inflammatory, antiarrhythmic, antianginal, etc.), but also to significantly reduce the severity of their side effects2. Carbamazepine is currently the main drug in the treatment of focal epilepsies. However, the proven effectiveness of carbamazepine is only for large convulsive attacks, and the side effects that limit its use in the clinic are clearly evident. The solution to this problem is the creation of a new, more effective antiepileptic drug that exhibits pronounced antidepressant, nootropic, neuroprotective and antioxidant properties based on a fixed combination of carbamazepine and thiotriazoline, which will also significantly reduce the amount of side effects. All medicinal products must meet quality standards. And the developed analytical methods included in the regulatory documentation for a pharmaceutical substance or a finished dosage form must be validated3. The purpose of our work is to validate the methodology for quantitative determination of accompanying impurities in "Carbatryl" tablets. Materials and methods: The following analytical equipment was used during the validation study: Chromatograph: LC-20 Prominence Shimadzu models in the following configuration: two LC-20AD pumps, SIL-20A autosampler, SPD-20AV detector, CTO-20A thermostat, CBM-20 ALITE system controller. Column: polymer column (Peek), size 100mm x 4.6mm, "Chromolith Speed RODRP-18e" cat. No. 1.02129.0001 production of the firm "MerkKGaA", Germany; Analytical balance model AUW 220D, manufactured by Shimadzu, Germany, uncertainty of weighing results 0.033 mg. Samples for studying the characteristics of correctness, convergence (precision) and range of application were prepared similarly to comparison solution B, only 0.25ml, 0.50ml, 0.75ml, 1.00ml and 1.25ml of the original solution of 3-methyl-1,2,4-triazolyl-5-thione and impurity A of carbamazepine. These amounts correspond to impurity concentrations equal to 50%, 75%, 100%, 125% and 150% of the maximum permissible amount7-9. In this case, the number of model solutions was reduced to 5, due to the high cost of the standard sample of impurity A. Results and discussion: The method is characterized by sufficient convergence, since the found value of the relative confidence interval of the value ?? for the impurities of thiotriazoline and carbamazepine does not exceed the critical value for the convergence of the results. The method is characterized by sufficient accuracy, since the criterion of insignificance of the systematic error of the method is fulfilled. The systematic error of the method meets the requirements of statistical (for the admixture of thiotriazoline) and practical (for the admixture of carbamazepine) insignificance: The high value of the correlation coefficient r = 0.99994 and 0.9998 satisfies the requirements of the acceptance criterion (r = 0.9998) and confirms the linear relationship between the taken and the amount of thiotriazoline and carbamazepine impurities found in the range from 50% to 150% relative to its nominal content in the preparation. Conclusions: the method of standardization of accompanying impurities in "Carbatryl" tablets was validated according to the following indicators: specificity, range of application, correctness and precision (convergence).


Cite this article:
Kucherenko Liudmyla, Nimenko Hanna, Khromylova Olga, Borsuk Serhii, Belenichev Igor, Hura Elina. Validation of the Method of Standardization of Concomitant impurities in "Carbatryl" Tablets. Research Journal of Pharmacy and Technology 2023; 16(9):4415-2. doi: 10.52711/0974-360X.2023.00721

Cite(Electronic):
Kucherenko Liudmyla, Nimenko Hanna, Khromylova Olga, Borsuk Serhii, Belenichev Igor, Hura Elina. Validation of the Method of Standardization of Concomitant impurities in "Carbatryl" Tablets. Research Journal of Pharmacy and Technology 2023; 16(9):4415-2. doi: 10.52711/0974-360X.2023.00721   Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-9-65


REFERENCES:
1.    Mazur I. Chekman S. Belenichev I. et al Development of drugs based on fixed combinations with antioxidants - a promising area of modern pharmacology. Pharmacology and Drug Toxicology. 2011; 5:199–200.doi.org/10.5455/bcp.20151003061901
2.    Kucherenko L., Nimenko G, Khromylova O, Borsuk S. Validation of quantitative determination methods of active substances in Carbatryl tablets. Research Journal of Pharmacy and Technology. 2022; 15(11):5148-3. doi: 10.52711/0974-360X.2022.00866
3.    Kucherenko L. Nimenko G. Vashchenko O. Vashchenko V. About co-determination of carbamazepine and thiotriazoline in the model mixture by HPLC. Message 2: Phase selection for co-determination of carbamazepine and thiotriazoline in the model mixture by HPLC (gradient elution). Pharmacom. 2016; 2: 27-32.doi.org/10.1586/14737175.5.5.587
4.    Kucherenko L. Khromylova O. Nimenko G. Borsuk S. Validation of the quantitative determination method of active substances in Arhitryl tablets. The Scientific Heritage. 2020; 51(2): 59-64. doi.org/10.14739/2409-2932.2018.2.133170
5.    Kucherenko L. Parniuk N. Khromylova O. Validation of the quantitation methods of 1-(ß-phenylethyl)-4-amino-1.2.4-triazole bromide substance by spectrophotometric method. Asian J Pharm Clin Res. 2018; 11(2): 231-234. doi.org/10.22159/ajpcr.2018.v11i2.22740
6.    Kucherenko L. Bidnenko O. Khromylova O. Validation of the spectrophotometric method for the determination of quantitative composition of S-2,6-diagenoxic acid of 3-methyl-1,2,4-triazolyl-5-thioacetate. Asian J Pharm Clin Res. 2018; 11(9): 91-94. DOI: 10.22159/ajpcr.2018.v11i9.22684
7.    Pakhomov V. Chromatography in chemical and pharmaceutical studies. Chem. Pharmac. Journal. 2003; 37(8): 55-56. doi.org/10.14739/2409-2932.2022.1.252374
8.    Oiestad EL, Johansen U, Christophersen AS Drug screening of preserved oral fluid by liquid chromatography-tandem mass spectrometry. Clin Chem. 2007; 53: 300–309. doi.org/10.14739/2409-2932.2021.3.242242
9.    Akhilesh G. Swati R. Arun P. Method Development and Photolytic Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(2): 29-33. www.researchgate.net/publication/30227131
10.    Satyanarayana L. Naidu S. Narasimha Rao M. et al. The Estimation of Raltigravir in Tablet dosage form by RP-HPLC. Asian J. Pharm. Ana. 2011; 1(3): 56-58. www.researchgate.net/publication/338209015
11.    Haque A. Shahriar M. Parvin N. Ashraful I. Validated RP-HPLC Method for Estimation of Ranitidine Hydrochloride, Domperidone and Naproxen in Solid Dosage Form. Asian J. Pharm. Ana. 2011; 1(3): 59-63. DOI: 10.13140/RG.2.2.20298.59849
12.    Satyanarayana L. Naidu S. Narasimha Rao M. Alok K. Suresh K. The Estimation of Darunavir in Tablet dosage form by RP-HPLC. Asian J. Res. Pharm. Sci. 2011; 1(3): 74-76. DOI: 10.22159/ijcpr.2017v9i5.22151
13.    Satyanarayana L. Naidu S. Narasimha Rao M. Latha S. The Estimation of Nilotinib in Capsule dosage form by RP-HPLC. Asian J. Pharm. Tech. 2011; 1(3): 82-84. DOI: 10.35629/7781-0602392402
14.    Yusuff I. Vijaya Vara Prasadb M. Shaheedhac S. Habeebd M. RP-HPLC Method for the Simultaneous Determination of Aspirin, Atorvastatin and Pioglitazone in Capsule Dosage Form. Asian J. Research Chem. 2008; 1(1): 40-42. : https://www.researchgate.net/publication/355820757
15.    Chitlange S. Bagri K. Sakarkar D. Stability Indicating RP-HPLC Method for Simultaneous Estimation of Valsartan and Amlodipine in Capsule Formulation. Asian J. Research Chem. 2008; 1(1): 15-18.https://www.researchgate.net/publication/233748674
16.    Nilesh J. Ruchi J. Hemant S. Deepak K. RP-HPLC Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Bulk Drug and its Combined Dosage Form. Asian J. Research Chem. 2008; 1(1): 29-31.  https://www.researchgate.net/publication/242645040
17.    Bagyalakshmi J. Vijayaraj S. Sindhu R. Method Development and Validation of Erythrosine (E127) Using RP-HPLC Coupled With PDA Detector. Asian J. Research Chem. 2008; 1(2): 95-96. DOI: 10.5958/0974-360Х.2020.00630.7
18.    Mahaveer S. Kashkhedikar S. Love S. Abhinav G. Amrish P. Development of RP-HPLC Method for Estimation of Carvedilol in Tablet Formulations. Research J. Pharm. and Tech. 2008; 1(1): 18-21. https://www.researchgate.net/publication/288405135
19.    Pawar H., Kothapalli L. Thomas A. Nanda R. Mare S. Simultaneous RP-HPLC Method for Estimation of Ezetimibe and Fenofibrate in Synthetic mixture. Research J. Pharm. and Tech. 2008;  1(1): 25-28. DOI:10.4172/2167-7689.1000169
20.    Jadhav R. Kendre P. Kolhe M. Lateef S. Shelke S. Godge R. RP-HPLC Method for Simultaneous Estimation of Ofloxacin and Ornidazole from Bulk and Tablets. Research J. Science and Tech. 2009; 1(1):43-46. https://www.researchgate.net/publication/280940308
21.    Sridharan D. Umarani Thenmozhi A. Pavan Kumar L. Aswani D. Venkata M. Phanikishore Y. Development and Validation of UV Spectrophotometric Method of Darifenacin Hydrobromide in Bulk and Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(3): 43-45. https://www.researchgate.net/publication/340874407
22.    Dibyajyoti S. Mayukh J. Supradip M. Target Discovery and Validation: Advances in Molecular Pharmacology. Asian J. Pharm. Ana. 2011; 1(2): 27-28. DOI: 10.5958/2231–5675

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