Analysis of Tolfenamic Acid using a Simple, Rapid, and Stability-indicating Validated HPLC Method


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Аннотация

Background:Tolfenamic acid (TA) belongs to the fenamates class of non-steroidal anti-inflammatory drugs. Insufficient information is available regarding the availability 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.

Об авторах

Sadia Kazi

Baqai Institute of Pharmaceutical Sciences, Baqai Medical University

Email: info@benthamscience.net

Muhammad Sheraz

Baqai Institute of Pharmaceutical Sciences,, Baqai Medical University

Email: info@benthamscience.net

Syed Musharraf

H.E.J. Research Institute of Chemistry, International Center for Chemical and Biological Sciences,, University of Karachi

Email: info@benthamscience.net

Sofia Ahmed

Baqai Institute of Pharmaceutical Sciences,, Baqai Medical University

Email: info@benthamscience.net

Raheela Bano

Dow College of Pharmacy, Dow University of Health Sciences

Email: info@benthamscience.net

Faraz Haq

H.E.J. Research Institute of Chemistry, International Center for Chemical and Biological Sciences, University of Karachi

Email: info@benthamscience.net

Zubair Anwar

Baqai Institute of Pharmaceutical Sciences,, Baqai Medical University

Автор, ответственный за переписку.
Email: info@benthamscience.net

Raahim Ali

, Baqai Institute of Pharmaceutical Sciences

Email: info@benthamscience.net

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