Validation & Stability Indicating RP-HPLC Method for Meloxicam Capsule. Developed and Validated as per ICH guidelines

      Аннотация: Meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3carboxamide-1,1 -dioxide) is an NSAID used in the management of rheumatic disease, which is distinguished by the fact that it is well tolerated by the stomach at the doses necessary for therapy. The anti-inflammatory and pain-relieving properties of Meloxicam make this active substance very interesting for use in pain therapy. Meloxicam act as nonselective inhibitor of the enzyme cyclooxygenase (COX), inhibiting both the cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) isoenzymes. A rapid, specific isocratic RP-HPLC method has been developed for the determination of Meloxicam capsules using a UV/diode array detector. The method was validated as per ICH guidelines and USP/NF. Therefore, this method can be useful for routine analysis of Meloxicam capsules as bulk drug and dosage form.

Ключевые слова: Analytical method development, HPLC, ICH, Meloxicam, Validation., DAD