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Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms

Introduction: Isoniazid (INH) is the anti-tuberculosis drugs being used to counter tuberculosis since 1952. Patients on INH should be given daily prophylactic pyridoxine (PYR) with 10-50 mg/day to prevent the development of isoniazid-induced neuropathy. Within the framework of this research, the UV-...

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Main Authors: Sudarman, Nur Suhaila, Haris @ Harith, Muhammad Salahuddin
Format: Article
Language:English
Published: IIUM Press 2023
Subjects:
RS Pharmacy and materia medica
Online Access:http://irep.iium.edu.my/103521/2/103521_Spectrophotometric%20simultaneous%20analytical%20%20%20method.pdf
http://irep.iium.edu.my/103521/
https://journals.iium.edu.my/ktn/index.php/jp/article/view/176
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spelling my.iium.irep.1035212023-11-24T08:52:49Z http://irep.iium.edu.my/103521/ Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms Sudarman, Nur Suhaila Haris @ Harith, Muhammad Salahuddin RS Pharmacy and materia medica Introduction: Isoniazid (INH) is the anti-tuberculosis drugs being used to counter tuberculosis since 1952. Patients on INH should be given daily prophylactic pyridoxine (PYR) with 10-50 mg/day to prevent the development of isoniazid-induced neuropathy. Within the framework of this research, the UV-Vis spectrophotometer is used to quantify simultaneously the drug content of INH and PYR. Methods: The standard curve for both INH and PYR were plotted using the concentration of 5 μg/ml, 10 μg/ml, 15 μg/ml, 20 μg/ml, 25 μg/ml, and 30 μg/ml and tablets were analysed using simultaneous equation method. The proposed method was validated by analytical method validation for the linearity, specificity, accuracy, intermediate precision, limit of detection (LOD), and limit of quantification (LOQ). Results: A regression equation of INH standard and sample were found to be y = 0.0279x + 0.0637 and y = 0.0280x + 0.0522 obtained from the calibration curve and linear with correlation coefficient (R2) values of 0.9950 and 0.9964, respectively. A regression equation of PYR standard and sample were y= 0.0267x + 0.0723 and y = 0.0259x + 0.0806 and to be linear with R2 values of 0.9981 and 0.9962, respectively. The result of accuracy obeyed the accepted criteria of percentage recovery in % to 102%. The method exhibited intermediate precision as demonstrated by relative standard deviation <2%. The LOD and LOQ of INH were 0.166 μg/ml and 0.5018 μg/ml while the LOD and LOQ of PYR were 0.122 μg/mL and 0.371 μg/mL, respectively in the pure form. In tablet dosage form, the LOD and LOQ of INH were 0.071μg/ml and 0.215 μg/m while LOD and LOQ of PYR give the result 0.124 μg/ml and 0.375 μg/ml, respectively. Conclusion: This spectrophotometric simultaneous analytical method validation for INH and PYR was successfully conducted with the notion to spearhead the development of INH and PYR in a single dosage form to improve compliance among tuberculosis patients. IIUM Press 2023-01-31 Article PeerReviewed application/pdf en http://irep.iium.edu.my/103521/2/103521_Spectrophotometric%20simultaneous%20analytical%20%20%20method.pdf Sudarman, Nur Suhaila and Haris @ Harith, Muhammad Salahuddin (2023) Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms. Journal of Pharmacy, 3 (1). pp. 9-18. E-ISSN 2773-5664 (In Press) https://journals.iium.edu.my/ktn/index.php/jp/article/view/176 10.31436/jop.v3i1.176
institution Universiti Islam Antarabangsa Malaysia
building IIUM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider International Islamic University Malaysia
content_source IIUM Repository (IREP)
url_provider http://irep.iium.edu.my/
language English
topic RS Pharmacy and materia medica
spellingShingle RS Pharmacy and materia medica
Sudarman, Nur Suhaila
Haris @ Harith, Muhammad Salahuddin
Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms
description Introduction: Isoniazid (INH) is the anti-tuberculosis drugs being used to counter tuberculosis since 1952. Patients on INH should be given daily prophylactic pyridoxine (PYR) with 10-50 mg/day to prevent the development of isoniazid-induced neuropathy. Within the framework of this research, the UV-Vis spectrophotometer is used to quantify simultaneously the drug content of INH and PYR. Methods: The standard curve for both INH and PYR were plotted using the concentration of 5 μg/ml, 10 μg/ml, 15 μg/ml, 20 μg/ml, 25 μg/ml, and 30 μg/ml and tablets were analysed using simultaneous equation method. The proposed method was validated by analytical method validation for the linearity, specificity, accuracy, intermediate precision, limit of detection (LOD), and limit of quantification (LOQ). Results: A regression equation of INH standard and sample were found to be y = 0.0279x + 0.0637 and y = 0.0280x + 0.0522 obtained from the calibration curve and linear with correlation coefficient (R2) values of 0.9950 and 0.9964, respectively. A regression equation of PYR standard and sample were y= 0.0267x + 0.0723 and y = 0.0259x + 0.0806 and to be linear with R2 values of 0.9981 and 0.9962, respectively. The result of accuracy obeyed the accepted criteria of percentage recovery in % to 102%. The method exhibited intermediate precision as demonstrated by relative standard deviation <2%. The LOD and LOQ of INH were 0.166 μg/ml and 0.5018 μg/ml while the LOD and LOQ of PYR were 0.122 μg/mL and 0.371 μg/mL, respectively in the pure form. In tablet dosage form, the LOD and LOQ of INH were 0.071μg/ml and 0.215 μg/m while LOD and LOQ of PYR give the result 0.124 μg/ml and 0.375 μg/ml, respectively. Conclusion: This spectrophotometric simultaneous analytical method validation for INH and PYR was successfully conducted with the notion to spearhead the development of INH and PYR in a single dosage form to improve compliance among tuberculosis patients.
format Article
author Sudarman, Nur Suhaila
Haris @ Harith, Muhammad Salahuddin
author_facet Sudarman, Nur Suhaila
Haris @ Harith, Muhammad Salahuddin
author_sort Sudarman, Nur Suhaila
title Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms
title_short Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms
title_full Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms
title_fullStr Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms
title_full_unstemmed Spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3D printed tablet forms
title_sort spectrophotometric simultaneous analytical method validation to determine isoniazid and pyridoxine in pure and 3d printed tablet forms
publisher IIUM Press
publishDate 2023
url http://irep.iium.edu.my/103521/2/103521_Spectrophotometric%20simultaneous%20analytical%20%20%20method.pdf
http://irep.iium.edu.my/103521/
https://journals.iium.edu.my/ktn/index.php/jp/article/view/176
_version_ 1783876080807968768
score 13.211869

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