Analysis of Tolfenamic Acid using a Simple, Rapid, and Stabilityindicating Validated HPLC Method
Copyright© Bentham Science Publishers; For any queries, please email at epubbenthamscience.net..
BACKGROUND: Tolfenamic acid (TA) belongs to the fenamates class of non-steroidal anti-inflammatory drugs. Insufficient information is available regarding the availa-bility of a reliable and validated stability-indicating method for the assay of TA.
OBJECTIVE: A relatively simple, rapid, accurate, precise, economical, robust, and stability-indicating RP-HPLC method has been developed to determine TA in pure and tablet dosage forms.
METHODS: The method was validated according to the ICH guideline, and parameters like linearity, range, selectivity, accuracy, precision, robustness, specificity, and solution stability were determined. TLC and FTIR spectrometry were used to ascertain the purity of TA. The specificity was determined with known impurities and after performing forced degradation, while the robustness was established by Plackett-Burman's experimental design. The mobile phase used for the analysis was acetonitrile and water (90:10, v/v) at pH 2.5. The detection of the active drug was made at 280 nm using a C18 column (tR = 4.3 min.). The method's ap-plicability was also checked for the yellow polymorphic form of TA.
RESULTS: The results indicated that the method is highly accurate (99.39-100.80%), precise (<1.5% RSD), robust (<2% RSD), and statistically comparable to the British Pharmacopoeia method with better sensitivity and specificity.
CONCLUSION: It was observed that the stress degradation studies do not affect the method's accuracy and specificity. Hence the proposed method can be used to assay TA and its tablet dosage form.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2023 |
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| Enthalten in: |
Anti-inflammatory & anti-allergy agents in medicinal chemistry - (2023) vom: 01. Nov. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kazi, Sadia Hafeez [VerfasserIn] |
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| Links: |
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| Themen: |
High-performance liquid chromatography |
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| Anmerkungen: |
Date Revised 01.03.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.2174/1871523022666230608094152 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM357935500 |
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| 100 | 1 | |a Kazi, Sadia Hafeez |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Analysis of Tolfenamic Acid using a Simple, Rapid, and Stabilityindicating Validated HPLC Method |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a Copyright© Bentham Science Publishers; For any queries, please email at epubbenthamscience.net. | ||
| 520 | |a BACKGROUND: Tolfenamic acid (TA) belongs to the fenamates class of non-steroidal anti-inflammatory drugs. Insufficient information is available regarding the availa-bility of a reliable and validated stability-indicating method for the assay of TA | ||
| 520 | |a OBJECTIVE: A relatively simple, rapid, accurate, precise, economical, robust, and stability-indicating RP-HPLC method has been developed to determine TA in pure and tablet dosage forms | ||
| 520 | |a METHODS: The method was validated according to the ICH guideline, and parameters like linearity, range, selectivity, accuracy, precision, robustness, specificity, and solution stability were determined. TLC and FTIR spectrometry were used to ascertain the purity of TA. The specificity was determined with known impurities and after performing forced degradation, while the robustness was established by Plackett-Burman's experimental design. The mobile phase used for the analysis was acetonitrile and water (90:10, v/v) at pH 2.5. The detection of the active drug was made at 280 nm using a C18 column (tR = 4.3 min.). The method's ap-plicability was also checked for the yellow polymorphic form of TA | ||
| 520 | |a RESULTS: The results indicated that the method is highly accurate (99.39-100.80%), precise (<1.5% RSD), robust (<2% RSD), and statistically comparable to the British Pharmacopoeia method with better sensitivity and specificity | ||
| 520 | |a CONCLUSION: It was observed that the stress degradation studies do not affect the method's accuracy and specificity. Hence the proposed method can be used to assay TA and its tablet dosage form | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Plackett-Burman's experimental design | |
| 650 | 4 | |a Tolfenamic acid | |
| 650 | 4 | |a high-performance liquid chromatography | |
| 650 | 4 | |a polymorphism. | |
| 650 | 4 | |a stability-indicating | |
| 650 | 4 | |a validation | |
| 700 | 1 | |a Sheraz, Muhammad Ali |e verfasserin |4 aut | |
| 700 | 1 | |a Musharraf, Syed Ghulam |e verfasserin |4 aut | |
| 700 | 1 | |a Ahmed, Sofia |e verfasserin |4 aut | |
| 700 | 1 | |a Bano, Raheela |e verfasserin |4 aut | |
| 700 | 1 | |a Haq, Faraz Ul |e verfasserin |4 aut | |
| 700 | 1 | |a Anwar, Zubair |e verfasserin |4 aut | |
| 700 | 1 | |a Ali, Raahim |e verfasserin |4 aut | |
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