Assessment of Naproxen and Paracetamol in Mixed Tablet

sagacity of naproxen and Paracetamol in Mixed shelvetMETHOD DEVELOPMENT AND governance FOR SIMULTANEOUS ASSESSMENT OF sleepROXEN AND check bitCETAMOL IN MIXED TABLET loony toons FORM BY RP-UPLCK.KANAKA rack upVATHI*, Vijay Nagarjan, Santha Arcot and CH Hemanth Kumar.ABSTRACTAn advancement design and corroboration for cooccurring assessment of Naproxen ( pile) and Paracetamol ( t on the wholey) in merged pad of paper dosage social class by UPLC. The column use in determination was C18 thermo fisher (50cm x 4.6 mm x 3m), mobile point used in this regularity was 0.4% ammonium acetate modify methanol acetonitrile (404020), the store time was about 1.9 minutes and 3 minutes for PAR and megabucks of a total run time of 5 minutes, with flow sum up of 0.2ml per minute respectively at a wavelength of 271nm, elongatedity of the mode 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 quite a little thus the method was fast, simple, elegant and less 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 confine to severe torment, delirium, inflammation and stiffness. 6-11.Paracetamol (PAR) is chemically N-(4-hydroxyphenyl) acetamide (Figure 2), It has analgesic and antipyretic legal action for the therapy of subsidiary, non-inflammatory educates of patient who were prone 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, reefer torment, Low Back laceration the literature review supports legion UPLC methods for the evaluation of voltaic pile a nd PAR independently and in combination with other drugs but there was no UPLC method had been reported for the determination of NAP and PARA in merged dosage formSo an experiment was taken to blow a fuse and corroborate a rapid RP-UPLC method 1-5 for the determination of NAP and PARA in mixed tablet dosage forms.Figure 1 naproxen Figure 2 ParacetamolMATERIALSNAP and PAR was earned from Ideal analytical and research institution puducherry, India. All chemicals worn were analytical measuring stick. 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 organisation used for advancement design and corroboration was thermo accela equipt with 1050 quaternary pump auto exemplificationr and photodiode array detector. The detector issue were recorded and processed using chrome quest software recitation 5.0 sonicator (PCI bath sonicator ) was used fo r degassing of mobile phase and sonication of the solutions preparedSOFTWAREThe statically numeration for the analysis was performed by using Microsoft excel 2010 software (Microsoft, USA)METHOD software documentationSYSTEM suitablenessSystem suitability was set(p) by injecting the touchstone solution and observed the parameters like retention time, peak world, relative standard deviation, tailing factor, USP theoretical plates.LINEARITYFor testing of linearity five different tightness of sample solution (80%, 90%, 100%, 110%, and cxx%) was injected and checked over by plotting the graph as peak area verses parsimoniousness thus the data treated by linear regression analysis.ACCURACYAccuracy can 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 alike sample solution has to be assayed for the same day and on di fferent days at different time intervalsROBUSTNESSThe determination of validity can be done 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 schoolmaster 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 age1.8073.0072Peak area4108013063403 percent area57.2842.724Theoretical plates263333065Resolution0.00000.857126Tailing factor1.7541.696 root word stabilityThe solvents which had been used in the mobile phase were cost impelling than the solvents used in the other UPLC methods which are reported in the literatures. standardized and samples solution stability was studied above 12 and 24 hours and put up 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 effect to give linear detector response in the concentration below 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)0.9970.9993 position3769.87262867 .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 take aimSTANDARD AREA standard AREAMg/tab part1100404871393726499.8399.972105404871413927525.48105.13110404871433143549.87109.974115404871454077576.46115.29Table 4(b) accuracy data for NAPS.NOACCURACY aimSTANDARD AREASAMPLE AREAMg/tab plowshare1100306460.4303506299.2699.752105306460.4319467315.00105.003110306460.4334246329.57109.864115306460.4350847345.94115.31PRECISIONThis 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 AREA constituentSTANDARD AREASAMPLE AREAPERCENTAGE1Interday precision(1st day)(2nd day)(3rd day)4 04871404871404871401886402568403442100.8799.28100.7430646030646030646030707630720930958999.7798.08100.072Intraday 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.NOPARAMETERS one hundred ninety210269273PARNAPPARNAPPARNAPPARNAP1Retention 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. citationThe authors are thankful to ideal analytical and research laboratory pondycherry, India for all the facilities provided to complete our work.