Abstract
An RP-HPLC method for simultaneous determination of 9 NSAIDs (paracetamol, salicylic acid, ibuprofen, naproxen, aceclofenac, diclofenac, ketorolac, etoricoxib, and aspirin) and their commonly prescribed combination drugs (thiocolchicoside, moxifloxacin, clopidogrel, chlorpheniramine maleate, dextromethorphan, and domperidone) was established. The separation was performed on Kromasil C18 (250 × 4.6 mm, 5 <i >μ</i>m) at 35°C using 15 mM phosphate buffer pH 3.25 and acetonitrile with gradient elution at a flow rate of 1.1 mL/min. The detection was performed by a diode array detector (DAD) at 230 nm with total run time of 30 min. Calibration curves were linear with correlation coefficients of determination <svg style="vertical-align:-2.3205pt;width:81.324997px;" id="M1" height="18.725" version="1.1" viewBox="0 0 81.324997 18.725" width="81.324997" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns="http://www.w3.org/2000/svg"> <g transform="matrix(.017,-0,0,-.017,.062,15.775)"><path id="x28" d="M300 -147l-18 -23q-106 71 -159 185.5t-53 254.5v1q0 139 53 252.5t159 186.5l18 -24q-74 -62 -115.5 -173.5t-41.5 -242.5q0 -130 41.5 -242.5t115.5 -174.5z" /></g><g transform="matrix(.017,-0,0,-.017,5.944,15.775)"><path id="x1D45F" d="M393 379q-9 -16 -28 -29q-15 -10 -23 -2q-19 19 -36 19q-21 0 -52 -38q-57 -72 -82 -126l-40 -197q-23 -3 -75 -18l-7 7q49 196 74 335q7 43 -2 43q-7 0 -30 -14.5t-47 -37.5l-16 23q37 42 82 73t67 31q41 0 15 -113l-11 -50h4q41 71 85 117t77 46q29 0 45 -26
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q0 -76 10 -138.5t37 -107.5t69 -45q32 0 55.5 25t35.5 68.5t17.5 91.5t5.5 105t-5.5 105.5t-18 92t-36 68t-56.5 24.5z" /></g><g transform="matrix(.017,-0,0,-.017,52.904,15.775)"><path id="x2E" d="M113 -12q-24 0 -39.5 16t-15.5 42q0 24 16 40.5t40 16.5t40 -16.5t16 -40.5q0 -26 -16 -42t-41 -16z" /></g><g transform="matrix(.017,-0,0,-.017,56.779,15.775)"><path id="x39" d="M244 635q90 0 143 -72t53 -177q0 -133 -65 -229.5t-171 -139.5q-79 -32 -140 -32l-5 30q109 18 185 91t101 186l-68 -36q-29 -16 -60 -16q-79 0 -129 51.5t-50 130.5q0 80 57 146.5t149 66.5zM228 602q-52 0 -78 -45.5t-26 -98.5q0 -69 36.5 -115.5t97.5 -46.5
q53 0 90 28q4 31 4 66q0 51 -9.5 95.5t-39 80.5t-75.5 36z" /></g><g transform="matrix(.017,-0,0,-.017,64.939,15.775)"><use xlink:href="#x39"/></g><g transform="matrix(.017,-0,0,-.017,73.098,15.775)"><use xlink:href="#x39"/></g> </svg>. Limit of detection (LOD) and Limit of quantification (LOQ) ranged from 0.04 to 0.97 <i >μ</i>g/mL and from 0.64 to 3.24 <i >μ</i>g/mL, respectively. As an application tool of quality by design, full factorial experimental design was used for the testing of robustness of the method. The prediction profiler correlating various parameters and responses was established from the results of design of experiments (DOE).
Highlights
Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently prescribed drugs worldwide and are used for relief of inflammatory, chronic, and acute pain conditions [1]
There are a number of liquid chromatographic methods reported in the literature [4–52] for the individual assays of these drugs and for the some of their combinations but so far no method has been reported for the simultaneous determination of cited NSAIDs in the presence of selected commonly prescribed combination drugs
We have developed a RP-HPLC method for the quantification of fifteen drugs (NSAIDs: paracetamol (PCM), salicylic acid (SA), ibuprofen (IBF), naproxen (NPX), aceclofenac (ACF), diclofenac (DCF), ketorolac (KTL), etoricoxib (ETC), and aspirin (ASP) and commonly prescribed combination drugs: thiocolchicoside (THC), moxifloxacin (MXF), clopidogrel (CLP), chlorpheniramine maleate (CPM), dextromethorphan (DXM), and domperidone (DOM)) using design of experiments (DOE) approach for robustness testing of the method
Summary
Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently prescribed drugs worldwide and are used for relief of inflammatory, chronic (e.g., rheumatoid arthritis, osteoarthritis, and gout), and acute (e.g., headache, postoperative pain, and orthopedic fractures) pain conditions [1]. NSAIDs formulations are available as over-the counter pharmaceutical preparations. There is need to develop new analytical methods for qualitative and quantitative analysis of NSAIDs and their combination drugs. There are a number of liquid chromatographic methods reported in the literature [4–52] for the individual assays of these drugs and for the some of their combinations but so far no method has been reported for the simultaneous determination of cited NSAIDs in the presence of selected commonly prescribed combination drugs. GC-MS method has been reported for some NSAIDs in water samples [56] and plasma and urine samples [57]. It is apparent that a more convergent method is required in order to make these procedures more straightforward and efficient for the estimation of NSAIDs and their combination drugs in their formulations
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