A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TOLFENAMIC ACID IN PRESENCE OF ITS PHARMACOPOEIAL IMPURITIES
Objective: The proposed research work was conducted to develop a single RP-HPLC method capable of separating two related impurities as well as degradation product of Tolfenamic acid (TA). The drug was subjected to various stress conditions recommended under ICH Q1A (R2) guidelines.
Methods: The desired separation of two Pharmacopoeial impurities and one degradant generated under oxidative stress was carried out using Sunfire ODS C-18 (250 x 4.6 mm, 5µm) column maintained at 40oC. Isocratic elution was carried out using acetonitrile and ammonium dihydrogen ortho phosphate buffer (10 mM, pH 2.5) in the ratio of 80:20 v/v. The detection was carried out at 205nm using flow rate of 1ml/min.
Results: The developed method was validated as per ICH Q2 (R1) guidelines for specificity, linearity, accuracy, precision, LOD, LOQ, and robustness. The drug was found stable under hydrolytic, photolytic and thermal stress conditions, but was found susceptible for degradation under oxidative stress.
Conclusion: The developed stability indicating method is found to be simple, rapid, accurate, precise and robust as compared to other proposed methods while determining TA in presence of its Pharmacopoeial impurities and degradation products. Hence the developed method can be used for analysis of stability samples of TA in presence of its related impurities.
This work is licensed under a Creative Commons Attribution 4.0 International License.