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2 Acta Chromatographica

2 2010

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Stability-indicating RP-HPLC method for analysis of telmisartan in the bulk drug and in formulations

Londhe S. V, Kaul N., Agrawal H., Mahadik K. R.

Acta Chromatographica

2010

Vol. 22, no. 4

539--548

A sensitive and reproducible HPLC method has been developed for quantitative analysis of telmisartan. The drug was separated from its degradation products on a C 18 column at ambient temperature with methanol-water 80:20 ( v / v ), pH 4.0 (adjusted by addition of orthophosphoric acid), as mobile phase at a flow rate of 1.0 mL min -1. Under these conditions the retention time of telmisartan was 4.85 ± 0.05 min. Quantification on the basis of peak area was achieved by UV detection at 225 nm; calibration plots were linear in the concentration range 10–60 μg mL -1 When the method was applied to a pharmaceutical formulation there was no chromatographic interference from tablet excipients. The method was validated for precision, robustness, recovery, and limits of detection and quantification. The drug was subjected to acidic and alkaline hydrolysis, and oxidising, dry heat, wet heat, and photodegrading conditions. Because the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.

Simultaneous HPTLC analysis of aspirin, atorvastatin calcium and clopidogrel bisulphate in the bulk drug and in capsules

Londhe S. V, Mulgund S. V, Deshmukh R. S, Jain K. S

Acta Chromatographica

2010

Vol. 22, no. 2

297--305

A simple, precise, and accurate HPTLC method has been established for simultaneous quantification of aspirin, atorvastatin calcium and clopidogrel bisulphate in the bulk drug and in a capsule dosage form. Chromatographic separation of the drugs was performed on aluminium foil plates precoated with silica gel 60 F 254 , with toluene-methanol-formic acid 6.5:3.5:0.1 ( v / v ) as mobile phase. Densitometric evaluation of the separated zones was performed at 254 nm. The three drugs were satisfactorily resolved with R F ± SD values 0.26 ± 0.01, 0.47 ± 0.01, and 0.78 ± 0.01 for aspirin, atorvastatin calcium, and clopidogrel bisulphate, respectively. The method was validated for linearity, specificity, accuracy, precision, and robustness, in accordance with ICH guidelines. Results from recovery studies indicated acceptable recovery of the drugs from the capsule dosage form. The intra-day and inter-day relative standard deviations were in the ranges 0.17–0.73% and 0.46–1.03% for aspirin, 0.36–0.87% and 0.44–0.62% for atorvastatin calcium, and 0.25–0.69% and 0.35–0.94% for clopidogrel bisulphate. The method proved to be a rapid and cost-effective quality-control tool for routine simultaneous analysis of aspirin, atorvastatin calcium, and clopidogrel bisulphate in the bulk drug and in a capsule formulation.