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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 tolueneacetonemethanolformic 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 16259750 ng/spot for paracetamol, 2501500 ng/spot for diclofenac potassium, and 100600 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.

The method established is simple, rapid, with high sample throughput, and can be used as a tool for quality control of G. sylvestre and its formulations.

The objective of current study was to develop a validated specific stability indicating reversed-phase liquid chromatographic method for the quantitative determination of desvenlafaxine in bulk sample and pharmaceutical dosage form in the presence of degradation products. Forced degradation studies were performed on bulk sample of desvenlafaxine as per ICH prescribed stress conditions using acid, base, oxidative and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed under acidic stress condition and the degradation product formed was identified by LC–MS and a degradation pathway for drug has been proposed. Successful separation of drug from degradation products formed under stress conditions was achieved on a SymmetryShield column C18 (5 μm, 250 mm×4.6 mm, i.d.) using the mobile phase consisting of a mixture of 0.2% (v/v) triethylamine in ammonium acetate (0.05 M; pH 6.5) and methanol using isocratic gradient.