Validated HPTLC method for simultaneous quantitation of paracetamol, diclofenac potassium, and famotidine in tablet formulation.

A sensitive, simple, selective, precise, and accurate HPTLC method of analysis for paracetamol, diclofenac potassium, and famotidine both as a bulk drug and in tablet formulation was developed and validated. The method used HPTLC aluminum plates precoated with silica gel 60F254 as the stationary phase, and the mobile phase consisted of toluene-acetone-methanol-formic acid (5 + 2 + 2 + 0.01, v/v/v/v). Densitometric evaluation of the separated zones was performed at 274 nm. This system was found to give compact spots for paracetamol (Rf value = 0.62 +/- 0.03), diclofenac potassium (0.75 +/- 0.02), and famotidine (0.17 +/- 0.03). The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 1625-9750 ng/spot for paracetamol, 250-1500 ng/spot for diclofenac potassium, and 100-600 ng/spot for famotidine. The method was validated for precision, robustness, and recovery according to International Conference on Harmonization guidelines. No chromatographic interference from the tablet excipients was found. Statistical analysis showed that the method was repeatable and selective for the simultaneous quantitation of the three drugs in tablet formulation and for routine quality control of raw materials of the drugs.