Abstract
A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantification of Meloxicam in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on Develosil ODS HG-5 RP C18, (15 cm × 4.6 mm i.d. 5 μm) column in isocratic mode with mobile phase consisting of acetonitrile: phosphate buffer(pH 3.4) (60:40) with a flow rate of 1 mL/min. The detection was carried out at 268 nm. The retention time of Meloxicam was found to be 2.09 min. The method was validated as per ICH guidelines. Linearity was established for Meloxicam in the range 20 – 120 μg/ml with R2 value 0.996. The percentage recovery of Meloxicam was found to be in the range 99.99-100.46%. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the estimation of the drug in bulk and tablet dosage forms. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible for the determination of Meloxicam for Quality Control level.
Highlights
IntroductionMeloxicam (MEL), shown in Figure 1, is chemically, 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H,1,2benzothaizine-3-carboxamide-1, 1-dioxide
Meloxicam (MEL), shown in Figure 1, is chemically, 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H,1,2benzothaizine-3-carboxamide-1, 1-dioxide. It is used for the treatment of osteoarthritis, rheumatoid arthritis, and pauciarticular and polyarticular course juvenile rheumatoid arthritis
Meloxicam pharmacological activity is greatly affected by the substituents on parent oxicam moiety e.g. change in methyl to ethyl at 2 positions causes complete suppression of activity (Lemke & Williams 2008)
Summary
Meloxicam (MEL), shown in Figure 1, is chemically, 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H,1,2benzothaizine-3-carboxamide-1, 1-dioxide. Meloxicam (MEL), shown, is chemically, 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H,1,2benzothaizine-3-carboxamide-1, 1-dioxide. It is used for the treatment of osteoarthritis, rheumatoid arthritis, and pauciarticular and polyarticular course juvenile rheumatoid arthritis. Several analytical methods for the determination of meloxicam by flourimetry (Hassan 2002), capillary electrophoresis (Nemutlu & Kir 2003), spectrophotometry (Hassan 2002), HPLC (Arayne et al 2005; Farzana & Pradeep 2009; Damle et al 2009), LC/MS (Wiesner et al 2003) and polarographic (Altıokka et al 2000; Radi et al 2001a; Altınöz et al 2002; Radi et al 2001b; Rao et al 2005) have been reported. The aim of the present work was to develop and validate a sensitive RP-HPLC method that can be implemented for the quantification of meloxicam in bulk as well as in its tablet dosage forms
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