Stability-indicating chromatographic methods for the determination of some oxicams.
Two sensitive and selective methods were developed for the determination of some oxicams, namely, lornoxicam (LOX), tenoxicam (TEX), and meloxicam (MEX), in the presence of their alkaline degradation products. The first method is based on the thin-layer chromatographic separation of the 3 drugs from their alkaline degradation products, followed by densitometric measurement of the intact drug spots for LOX, TEX, and MEX at 380, 370, and 364 nm, respectively. The developing systems used for separation are ethyl acetate-methanol-26% ammonia (17 + 3 + 0.35, v/v/v) for LOX and TEX and chloroform-n-hexane-96.0% acetic acid (18 + 1 + 1, v/v/v) for MEX. The linear ranges were 0.25-6.0 microg/spot for LOX and TEX and 0.5-10 microg/spot for MEX, with mean recoveries of 99.80 +/- 1.32, 100.57 +/- 1.34, and 100.71 +/- 1.57%, respectively. The second method is based on the liquid chromatographic separation of the 3 drugs from their alkaline degradation products on a reversed-phase C18 column, using mobile phases of methanol-acetonitrile-acetate buffer, pH 4.6 (4.5 + 0.5 + 5.0, v/v/v) for LOX and MEX and methanol-acetonitrile-acetate buffer, pH 4.6 (1.9 + 0.1 + 3.0, v/v/v) for TEX at ambient temperature. Quantification is achieved by UV detection at 280 nm, based on peak area. The linear ranges were 0.5-20 microg/mL for LOX and TEX and 1.25-50 microg/mL for MEX, with mean recoveries of 99.81 +/- 1.01, 98.90 +/- 1.61, and 100.86 +/- 1.55%, respectively. The methods were validated according to guidelines of the International Conference on Harmonization. The developed methods were successfully applied to the determination of LOX, TEX, and MEX in bulk powder, laboratory-prepared mixtures containing different percentages of degradation products, and pharmaceutical dosage forms.
Taha
Elham Anwer
EA
National Organization for Drug Control and Research, 6 Abou Hazem St, Pyramids Ave, PO Box 29 Giza, Egypt. dr_elhamtaha@hotmail.com
Salama
Nahla Nour
NN
Abdel Fattah
Laila el-Said
Lel-S
D002853:Chromatography, Liquid; D002855:Chromatography, Thin Layer; D000077239:Meloxicam; D010894:Piroxicam / Q000031:analogs & derivatives* / Q000032:analysis*; D012680:Sensitivity and Specificity; D013843:Thiazines / Q000032:analysis*; D013844:Thiazoles / Q000032:analysis*
D013843:Thiazines; D013844:Thiazoles; D010894:Piroxicam; C059451:lornoxicam; D000077239:Meloxicam; C032801:tenoxicam