HPTLC double development and validation of mefenamic acid and tranexamic acid in combined tablet dosage form

The present study was undertaken to develop and validate simple, rapid, precise, accurate and robust high performance thin layer chromatographic (HPTLC) method for simultaneous estimation of mefenamic acid (MFNC) and tranexamic acid (TXA) in bulk drugs and tablet formulation. Double development technique was employed in the present study in the chromatographic separation of drugs on aluminium plates precoated with silica gel 60 F254. The solvent system used was toluene: methanol (8:2, v/v) for MFNC and methanol: glacial acetic acid (9:1, v/v) for TXA. The densitometric evaluation of separated bands was carried out at 287 nm for MFNC & 525 nm for TXA using 0.2% ninhydrin as derivatizing reagent. Retardation factors of MFNC and TXA were found to be 0.48 ± 0.02 and 0.72 ± 0.02, respectively. Linearity of MFNC and TXA was found in the concentration range of 30 - 400 ng/band and 30 - 500 ng/band, respectively. The % assay (Mean ± S.D.) was found to be 98.91% ± 1.38 & 99.66% ± 1.44 for MFNC and TXA respectively. HPTLC method was validated for linearity, accuracy, precision, specificity, robustness in accordance with International Conference on Harmonisation [ICH] guidelines. The proposed HPTLC method has been successfully applied for the simultaneous analysis of MFNC and TXA in tablet dosage form.
Author(s): Naresh Reddy Kontham, Sachin E. Potawale, Satish Y. Gabhe and Kakasaheb R. Mahadik

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