Abstract
The aim of this study is to develop and validate a reliable, fast, and precise High-performance liquid chromatography (HPLC) method for the assay of diclofenac sodium (DIC) from previously optimized new orodispersible tablets (ODTs) developed with co-processed excipients.The method was conducted on an HPLC Agilent 1200, Zorbax C18 column, mobile phase of orthophosphoric acid solutions 0.1%, acetonitrile and methanol in the ratio (40:50:10 v/v/v) with a flow rate of 1.5 mL/min with isocratic elution and a total run time of 5 min. Detection of diclofenac sodium was carried out at 276 nm. The method was validated for linearity, precision, accuracy, robustness as per international guidelines. The developed method was found to be accurate, precise, fast, without interference from the co-processed excipients and can be useful for routine quality control analysis of diclofenac sodium in ODTs.
Highlights
Diclofenac sodium (DIC) is sodium 2-[(2,6-dichlorophenyl) amino]phenil-acetate is among the most commonly prescribed non-steroidal anti-inflammatory drug (NSAIDs) due to its anti-inflammatory, antipyretic, and analgesic effects [1,2]
As a result of optimizing the formulation of orodispersible tablets (ODTs) with diclofenac sodium and co-processed excipients, PharmaburstTM 500 and Prosolv® ODT [10,11] the following obtained formulas were further subjected to in vitro qualitative and quantitative diclofenac sodium evaluation.PharmaburstTM500 is a mixture of co-processed excipients consisting of crospovidone, mannitol, sorbitol and precipitated silicon or Aerosil 200
It performs the functions of disintegrant, due to crospovidone considered as a super-disintegrant, diluent, sweetener, sliding, agglutinate [11].There is not a single chromatographic method of separation and assay for diclofenac sodium in the literature
Summary
Diclofenac sodium (DIC) is sodium 2-[(2,6-dichlorophenyl) amino]phenil-acetate is among the most commonly prescribed non-steroidal anti-inflammatory drug (NSAIDs) due to its anti-inflammatory, antipyretic, and analgesic effects [1,2]. Contrary to the action of many traditional NSAIDs, DIC inhibits cyclooxygenase (COX)-2 enzyme with greater potency than it does COX-1 [3, 4] in vitro and in vivo, decreasing the production of prostaglandins, prostacyclines and thromboxanes It is widely used in management of mild to moderate pain, when inflammatory is present as in cases of rheumatoid arthritis, osteoarthritis [5], ankylosing spondylitis, gouty arthritis [6], tendinitis, and bursitis [7], and certain nonrheumatic conditions, and in other inflammatory painful conditions such as postoperative pain, treatment of dysmenorrhea, back pain, sciatica [8, 9]. Prosolv® ODT, co-processed excipient, high functionality is a mixture of microcrystalline cellulose, colloidal silicon dioxide, mannitol, fructose and crospovidone It performs the functions of disintegrant, due to crospovidone considered as a super-disintegrant, diluent, sweetener (mannitol), sliding (silicon dioxide), agglutinate (through fructose) [11].There is not a single chromatographic method of separation and assay for diclofenac sodium in the literature. Methanol, acetonitrile, orthophosphoric acid were obtained from Lab Scan (Germany), bidistilled water obtained with a Milli-Q water purification system (Millipore, Watford, England) with a minimum resistivity of 18.2 MΩ and a maximum content of organic compounds TOC maximum 30 ppb; 240 mm quantitative filter paper (Schleicher & Schuell, Germany)
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