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Development and validation of a stability-indicating HPTLC method and HPLC method for simultaneous estimation of lornoxicam and paracetamol in combined tablet dosage forms

Author(s): Dinesh Kumar Jain | Nitin Dubey, Yash Sharma

Journal: International Journal of Pharmacy and Biomedical Sciences
ISSN 0976-5263

Volume: 02;
Issue: 02;
Start page: 55;
Date: 2011;
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Keywords: Lornoxicam | Paracetamol | Simultaneous estimation | HPLC method development | HPTLC method development | Method validation | Stability-indicating method

A simple, precise and stability-indicating high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatographic (HPTLC) method for simultaneous estimation of lornoxicam (LOR) and paracetamol (PCM) in tablet formulations has been developed and validated. The HPLC separation was achieved on a Phenomenex Luna C18 column using methanol: acetonitrile: water (50:30:20, v/v/v) as mobile phase (pH 3.8) at a flow rate of 1.0 mL/min at ambient temperature. Quantitation was achieved with UV detection at 290 nm over the concentration range 2-10 μg/mL and 5-100 μg/mL with mean recovery of 99.71 ± 0.189 % and 99.55 ± 1.10% for LOR and PCM, respectively. LOR (290 nm) and PCM (256 nm) were chromatographed on silica Gel 60 F254 TLC plate using chloroform: methanol: ethyl acetate: acetic acid (20:15:55:10, % v/v/v/v) as the mobile phase and then scanned. The compact bands at Rf 0.23 ± 0.01 and 0.60 ± 0.02 respectively, were observed for LOR and PCM. Linear regression analysis revealed linearity in the range of 300 – 550 ng/band and 100-500 ng/band for LOR and PCM respectively. Drugs were subjected to acid and alkali hydrolysis, oxidation, thermal and photo-degradation treatments. The degraded products were well separated from the pure drug. Statistical analysis proved that the method is precise, accurate, selective and economical and may be used for routine simultaneous estimation of LOR and PCM for tablet formulations.
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