DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF MELOXICAM IN PHARMACEUTICAL DOSAGE FORM

Mrunal Baburao Chavan*, Dr. S. C. Kale, Dr. Aijaz Sheikh and Dr. K. R. Biyani

ABSTRACT

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to treat rheumatoid arthritis, acute exacerbations of osteoarthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. It is given in a single oral dose of 7.5mg, increased if necessary, and may be given by rectal suppository in doses similar to orally. Meloxicam has a greater inhibitory activity against the inducible isoform of cyclooxygenase (COX-2) than against the constitutive isoform (COX-1). COX-1 induces the synthesis of prostacyclin, which is responsible for vascular homeostasis, platelet aggregation, renal function, and gastric cytoprotection. Meloxicam's anti-inflammatory and analgesic properties are similar to non-selective NSAIDs, but it has both gastric mucosal and renal protective properties. The reported side effects of meloxicam are similar to those of NSAIDs, such as abdominal pain, anemia, and edema, with an increased risk of serious gastrointestinal adverse events, including ulceration and bleeding. The aim of the present study is to develop and validate the RP-HPLC method for estimating Meloxicam in Pharmaceutical Dosage Form, focusing on the application of suitable analytical techniques, optimization, and validation in accordance with ICH guidelines, while selecting the appropriate drug and developing an analytical methodology. In this study, we found that the pharmaceutical dose tablet formulations containing Meloxicam (MLC) may be accurately measured using the RP-HPLC method. The RP-HPLC technique is sensitive, accurate, precise, and repeatable; it also demonstrates high repeatability. Meloxicam (MLC) tablet dosage formulation analysis may also be conducted with success. These techniques do not experience any influence from additives, matrices, etc. To further understand these trials, additional research on other medication formulations is needed.

Keywords: Meloxicam; RP-HPLC; Validation; ICH guidelines; Cyclooxygenase.