Assessment of Naproxen and Paracetamol in Mixed Tablet

Assessment of Naproxen and Paracetamol in Mixed TabletMETHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS judgment OF pilingROXEN AND equivalenceACETAMOL IN MIXED TABLET DOSAGE FORM BY RP-UPLCK.KANAKA comparabilityVATHI*, Vijay Nagarjan, Santha Arcot and CH Hemanth Kumar.ABSTRACTAn advancement design and corroboration for simultaneous appraisal of Naproxen (NAP) and Paracetamol (equation) in merged tablet dosage form by UPLC. The column use in object was C18 thermo fisher (50cm x 4.6 mm x 3m), sprightly phase used in this method was 0.4% ammonium acetate lover methanol acetonitrile (404020), the retention time was about 1.9 legal proceeding and 3 minutes for PAR and NAP of a total run time of 5 minutes, with flow rate of 0.2ml per minute respectively at a wavelength of 271nm, linearity of the method was linear over the range of 38.496 to 57.664g/ml for Paracetamol and 64.096 to 95.968g/ml of Naproxen respectively with a correlation of 0.999 for simultaneous assessment for PAR and NAP thus the method was fast, simple, elegant and little time consuming methodKeywords Naproxen, Paracetamol RP-UPLC, Method validationINTRODUCTIONNaproxen is chemically 2-Naphthaleneacetic acid, 6-methoxy--methyl-(s)-(+)-(s)-6 methoxy--methyl-2-naphthaleneacetic acid as shown in (Figure 1). It is a non-steroidal anti-inflammatory drug commonly used for minimizing of moderate to severe torment, delirium, inflammation and stiffness. 6-11.Paracetamol (PAR) is chemically N-(4-hydroxyphenyl) acetamide (Figure 2), It has analgesic and antipyretic activity for the therapy of subsidiary, non-inflammatory conditions of patient who were given over to gastric symptoms 12-14.The merger of these two drugs are used in the remedy 11 of Musculoskeletal Disorder (Sprain/Strains) Trauma Fractures/injuries), Occupational affliction, Joint torment, Low Back laceration the books review supports legion UPLC methods for the evaluation of NAP and PAR independently and in combination with other drug s but There was no UPLC method had been reported for the design of NAP and PARA in merged dosage formSo an experiment was taken to expand and corroborate a rapid RP-UPLC method 1-5 for the ratiocination of NAP and PARA in mixed tablet dosage forms.Figure 1 NAPROXEN Figure 2 ParacetamolMATERIALSNAP and PAR was earned from deification analytical and research institution puducherry, India. All chemicals worn were analytical standard. The pharmaceutical tablet dosage form used in this study was NAPROSYN P with a label claim of NAP 300mg and PAR 500mg were purchased from local pharmacy.INSTRUMENTATION AND APPARATUSThe uplc system used for advancement design and corroboration was thermo accela equipped with 1050 quaternary pump auto sampler and photodiode array detector. The detector output were recorded and processed using chrome quest software version 5.0 sonicator (PCI bath sonicator ) was used for degassing of mobile phase and sonication of the solutions preparedSOFTWAREThe static ally calculation for the analysis was performed by using Microsoft excel 2010 software (Microsoft, USA)METHOD CORROBORATIONSYSTEM SUITABILITY governing body suitability was determined by injecting the standard solution and observed the parameters like retention time, peak area, relative standard deviation, tailing factor, USP theoretical plates.LINEARITYFor exam of linearity five different concentration of sample solution (80%, 90%, 100%, 110%, and 120%) was injected and checked over by plotting the graph as peak area verses concentration thus the data treated by linear regression analysis. the trueAccuracy goat be done by injecting the sample solution with known standard concentration and the amount of percentage recovery gives the accuracy of sample.PRECISIONPrecision can be evaluated by Interday and intraday, were the comparable sample solution has to be assayed for the same day and on different days at different time intervalsROBUSTNESSThe determination of robustness can be d one by changing the experimental condition deliberately. The condition may include of changing in mobile phase flow rate, pH and temperature, the percentage of RSD, tailing factor, resolution, were cross check with the original data.RESULT DISCUSSIONThe method has validated according to the norms of international harmonization of conference (ICH) guidelines with regards of system suitability, linearity, accuracy, precision and robustness as followsSYSTEM SUITABILITYThe system suitability tests were carried out to evaluate the resolution and reproducibility of the system for the analysis. The results of the system suitability test were summarized in Table No.1.Table 1 System suitability resultsS.NoPARAMETERSPARNAP1Retention Time1.8073.0072Peak area4108013063403 dowry area57.2842.724Theoretical plates263333065Resolution0.00000.857126Tailing factor1.7541.696Solution stabilityThe solvents which had been used in the mobile phase were equal effective than the solvents used in the other UPLC methods which are reported in the literatures.Standard and samples solution stability was studied above 12 and 24 hours and launch stable against the freshly prepared standard.Table2. Results of Solution stabilityTime (hrs)Percentage AssayPercentage difference in assayPAR NAPPAR NAPInitial99.9299.990.0020.001After 12 hrs99.5299.570.0030.002After 24 hrs99.1299.190.0010.002LINEARITYLinearity of the method was evaluated at 5 different concentration levels of 38.496 to 57.664g/ml for Paracetamol and 64.096 to 95.968g/ml of Naproxen respectively. Both the drugs were found to give linear detector response in the concentration under study with correlation coefficient of 0.997 and 0.999 for PAR and NAP respectively.Table3 Linearity study for NAP and PARS.NOPARAMETERSPARNAP1Linearity range38.49 57.664g/ml64.09 -95.96g/ml2Correlation coefficient (r2)0.9970.9993Slope3769.87262867.15914Intercept1567.73620.1591ACCURACYAccuracy of the method was determined by recovery test. The percentage recovery was found to be within the concentration of 100 to 115 as 100, 105, 110, and 115 (Table4). All results indicate that the method is highly accurate.Table 4(a) accuracy data for PARS.NOACCURACY LEVELSTANDARD AREASAMPLE AREAMg/tabPERCENTAGE1100404871393726499.8399.972105404871413927525.48105.13110404871433143549.87109.974115404871454077576.46115.29Table 4(b) accuracy data for NAPS.NOACCURACY LEVELSTANDARD AREASAMPLE AREAMg/tabPERCENTAGE1100306460.4303506299.2699.752105306460.4319467315.00105.003110306460.4334246329.57109.864115306460.4350847345.94115.31PRECISIONThis method was validated for its inter-day and intra-day precision. The results (table4) obtained were within the acceptable limit.Table 5 results for precision studiess.noParameter(units)PARNAPSTANDARD AREASAMPLE AREAPERCENTAGESTANDARD AREASAMPLE AREAPERCENTAGE1Interday precision(1st day)(2nd day)(3rd day)404871404871404871401886402568403442100.8799.28100.7430646030646030646030707630720930958999.7798.08100.072Intrad ay precision1sthrs2nd hrs3rd hrs404871404871404871402645401507400271100.17100.65100.4930646030646030646030995730743830794699.8299.76100.073Average100.36699.5954SD0.5840.755RSD0.5820.758ROBUSTNESSThe robustness of the method was determined and the percentage RSD of the results was found to be less than 2.0%, which demonstrate that the developed method is robust.Table6. Results of Robustness parameterCHANGED PARAMETERSFLOW RATEWAVE LENGTHS.NOPARAMETERS190210269273PARNAPPARNAPPARNAPPARNAP1Retention time1.9383.2151.702.8321.8103.0051.8103.0072Area4629473473344061343067844321543228524262953474423% area57.1342.8756.9743.0357.2442.7655.1044.90CONCLUSIONThus, the above stated method for determination of PAR and NAP by UPLC method concludes as it can be quantified simultaneously by using of isocratic mobile phase of 0.4% ammonium acetate buffer methanol acetonitrile (404020), by using of PDA detector at 271 nm. Thus the proposed method is simple, precise, accurate, rapid and sensitive, where it can be applied successfully for the assessment of PAR and NAP in combined pharmaceutical formulations.ACKNOWLEDGEMENTThe authors are thankful to ideal analytical and research laboratory pondycherry, India for all the facilities provided to complete our work.