Abstract
Meloksikamın MEL farmasötik preparatlardan 7,5 ve 15 mg içeren tabletler tayini için ters faz yüksek performanslı sıvı kromatografisi yöntemi geliştirilmiştir. MEL ve tenoksikam IS ters faz kolon üzerinde Nucleosil 100-5 C18 150 x 4.6 mm i.ç., 5 μm partikül çapı 50 mM fosfat-asetonitril- metanol hareketli fazı ile 1 mL dak-1 akış hızında analiz edilmiştir ve UV tayin 366 nm’de gerçekleştirilmiştir. MEL ve IS’nin alıkonma süreleri sıra ile 11,1 ve 5,6 dakikadır. Doğrusallık aralığı 0,20-15,00 μg mL–1 olarak bulunmuştur. Yöntem kesinliğe, doğruluğa, hassaslığa ve tutarlılığa göre valide edilmiştir. Geliştirilen yöntemin doğru, kesin, hassas, tutarlı ve MEL farmasötik preparatlardan tayini için kullanışlı olduğuna karar verilmiştir.
Keywords
Abstract
A reversed-phase high-performance liquid chromatographic method is developed for the determination of meloxicam MEL in pharmaceutical preparations tablets containing 7.5 and 15 mg MEL . MEL and the internal standard tenoxicam IS were analysed on a reversed-phase column Nucleosil 100-5 C18 150 x 4.6 mm i.d., 5 μm particle size with a mobile phase containing 50 mM phosphate buffer – MeCN – MeOH 50:15:35 v/v/v pH 5.5 at a flow-rate of 1.0 mL min-1 and UV detection was performed at 366 nm. The retention times for MEL and IS were 11.1 and 5.6 min, respectively. The linearity range was found to be 0.20-15.00 μg mL–1. LOD and LOQ were found to be 0.02 μg mL–1 and 0.20 μg mL–1, respectively. The method was validated and it was concluded that the developed method was accurate, sensitive, precise, rugged and useful for the quality control of MEL in pharmaceutical preparations. The tablet results were compared with a validated capillary zone electrophoretic method and there was no statistically difference between the results at the 95 % confidence level.
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Details
| Primary Language | English |
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| Journal Section | Research Article |
| Authors | |
| Publication Date | June 1, 2007 |
| Published in Issue | Year 2007 Issue: 2 |