Title:Analysis of Tolfenamic Acid using a Simple, Rapid, and
Stability-indicating Validated HPLC Method
Volume: 23
Issue: 1
Author(s): Sadia Hafeez Kazi, Muhammad Ali Sheraz, Syed Ghulam Musharraf, Sofia Ahmed, Raheela Bano, Faraz ul Haq, Zubair Anwar*Raahim Ali
Affiliation:
- Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, 75340, Karachi, Pakistan
Keywords:
Tolfenamic acid, high-performance liquid chromatography, validation, stability-indicating, Plackett-Burman's experimental design, polymorphism.
Abstract:
Background: Tolfenamic acid (TA) belongs to the fenamates class of nonsteroidal
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 stabilityindicating
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 applicability
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.
