Estimation of Desloratidine and Montelukast by UV

Estimation of Desloratidine and Montelukast by UV concurrent ESTIMATION OF diethylstilboestrolLORATIDINE AND MONTELUKAST IN COMBINED PHARMACEUTICAL DOSAGE FORM BY UV SPECTROSCOPYETTA.NAVEEN KUMAR*, D.SIREESHA, VASUDHA BAKSHI.ABSTRACT A simple, accurate,precise and economical procedure for synchronal estimation of Desloratidine and Montelukast in combine tablet dosage cause has been true utilizing concept of coincidental equation method acting. The method is based upon determination of Desloratidine at 269nm and Montelukast at 283nm in wood alcohol. Different analytical parameters such as linearity, precision, truth and ruggedness were determined according to ICH guidelines. Deslortidine and Montelukast at their respective wavelength shows linearity in the assiduity range of 5-30 mcg/ml and 2-22mcg/ml.respectively.The method was validated statistically. The results of abstract readying given as percentage of label claim were free-base to be century.4% and 101.% for Deslor atidine and Montelukast respectively. Therefore, the proposed method can be used for the routine compend of both drugs cooccurringly in quality control laboratories.Keywords Desloratidine, Montelukast,simultaneous estimation, methanol instaurationDesloratidine(DES) is chemically 8- chloro-6, 11-dihydro-11-(4-piperdinylidene)- 5H benzo5,6cyclohepta1,2-bpyridine.Desloratidine is a anti- histamine clinically effective drug in the word of Asthama. It is soluble in methanol, ethanol, water and practically insoluble in acetonitrile. Montelukast (MON),is2-1-((1R)-1-03-(E)-2-(7-chloroquinolin-2-yl)ethenylphenyl-3-2-(2-hydroxypropan-2-)phenylpropylsulfanylmethyl)cyclopropylacetic loony toons is a widely used as Anti-arrhythmatic and Anti-asthamatic agents. Montelukast and Desloratidine is available in combined dosage engineers as film coated tablets (MONDESLOR). Each tablet contains 10mg of Montelukast and 5 mg of Desloratidine. It is used for the treatment of Asthma.For this combinati on derivative spectroscopic methods and subvert phase liquid chromatographic methods argon reported. However ,there is no practise reported on combination of these drugs by simultaneous equation method. hence fast, simple, and accurate spectrophotometric method was developed by applying simultaneous equation method, for the simultaneous estimation of both the drugs in tablet dosage form by uv spectrophotometry.MATERIALS AND METHODSINSTRUMENT SPECIFICATIONS UV Spectrophotometer, Shimadzu, model 1800CHEMICALS AND REAGENTS Methanol guarded from local market, makePure Deslortadine and Montelukast were obtained as gift sample from Gujarat organics Ltd,GujaratThe tablet dosage form MONDESLOR( claim 10mg Montelukast and 5mg Desloratidine) was procured from local market.PREPARATION OF STANDARD STOCK SOLUTIONSThe 10 mg of mensuration Montelukast and Desloratidinewere weighed accurately and transferred into 100 ml chromatric flasks seperately. They were dissolved in methanol and dilute d up to the mark by using the resultant methanol to obtain a final concentration of 100g/ml. The resulting firmness of purposes were used as a working regulation solutions.The fractional instalment of stock solutions of Montelukast and Desloratidine were diluted approximately with methanol to obtain concentration of 10 mcg/ml of each drugs.These solutions were scanned in the range of 200-400 nm in 1cm cell against blank .From the overlain spectra the wavelength selected for the estimation are 269 nm and 283nm for montelukast and desloratidine respectively.PREPARATION OF assay SOLUTIONSFor analytic thinking of commercial sayings 20 tablets (MONDESLOR) each cantaining 10mg of montelukast and 5mg of desloratidine were accurately weighed and the average lean was calculated and finely powdered.A quantity equivalent to 10mg of montelukast dissolved in methanol in 100ml gaudinesstric flask and to it 5mg of desloratidine was added(standard addition method). sonicated to dissolve it completely and volume was made to the mark with methanol .mixed well and perked through 0.45m filter to modernise the final concentration of 100g/ml. finally 10mcg/ml working concentration of each desloratidine and montelukast was prepared.This solution was scanned over the range of 200-400 nm ,using two sampling wavelengths 269nm and 283nm determined the concentration of these drugs in tablet formulationUsing the formula.CDES = A2ay1-A1ay2/ax2 ay1-ax1ay2CMON = A1ay2 A2ax1/ax2ay1-ax1ay2A1 = absorbance of formulation at 269nm.A2 = absorbance of formulation at 283 nm.ax1 = absorptivity of Desloratidine at 269 nm.ax2 = absorptivity of Desloratidine at 283 nm.ay1 = absorptivity of Montelukast at 269 nm.ay2 = absorptivity of Montelukast at 283 nm.CDES = concentration of Desloratidine.CMON = concentration of Montelukast.VALIDATION OF THE METHOD1) LINEARITY Standard stock solution of Montelukast and Desloratidine 10 mg of montelukast and desloratidine were accurately weighed a nd transferred into a clean and dry 100 ml volumetric flasks, dissolved with sufficient volume of methanol seperately .The volume was then made up to 100 ml with methanol to obtain the concentration of 100 g/ml. Working standard solution The aliquot portion of the stock solution was diluted approximately with methanol to get a concentration of 2-22 mcg/ml of montelukast and 5-30mcg/ml of desloratidine. Serial dilutions of concentration range were prepared from the working standard solution. These dilutions were scanned at the detection wavelength of 269 nm and 283nm using methanol as blank. The regression equation, Y- intercept and correlation coefficient were calculated. The linearity was thus determined and the concentration range was selected.2) desexualize OF DETECTION AND LIMIT OF QUANTITATIONThe LOD and LOQ were separately determined based on calibration roll. The residual standard balance of opinion of a regression line or the standard excursion of y- intercepts of regre ssion lines were used to calculate the LOD and LOQ.I. Formula for LOD (g/ml)LOD = 3.3 x SD / SWhere,SD = The standard deviation of the responseS = The slope of the calibration curve (mean)II. Formula for LOQ (g/ml)LOQ = 10 x SD / SWhere,SD = The standard deviation of the responseS = The slope of the calibration curve (mean)3) ACCURACYThe accuracy of the method was ascertained by carrying out recuperation studies using standard addition method. The recovery studies are performed to determine if there was any peremptory or negative interference from excipients present in the formulation. The percentage recovery results revealed that the values were near to 100%, which indicates that the proposed method is accurate as the results are within the official limits. It also reveals that the commonly used excipients and additives in the formulation were not interfering with the proposed method( fudge no4)4) PRECISIONPrecision was put in by carrying out the summary of the standard drugs a t two distinct concentrations in the linearity range of drugs for three times on the very(prenominal) day. Each concentration was applied in duplicate and % RSD was calculated (Table no 5)RESULTS AND DISCUSSIONMontelukast and Desloratidine showed maximum absorbance in Methanol at 269 and 283 nm.The proposed method for simultaneous estimation of both the drugs was validated as per the ICH guidelines The linearity was observed in the concentration range of 2-22 mcg/ml for montelukast and 5-50mcg/ml for Desloratidine with regression co-efficient of 0.998 and 0.998. centre of drugs estimated by the proposed method was in good agreement with the label claim.The accuracy of the method was assessed by recovery experiments . Recovery was close to 100% for both the drugs. closing curtainThe present study comprises a UV spectroscopic method of analysis for the simultaneous estimation of montelukast and Desloratidine in tablet dosage form.From the study of substantiation parameters,itwas ob served that the method is specific,accurate,precise,reproducible .The proposed method could be applied to routine analysis in quality control laboratories.Table No.1 Calibration data of deslortadine. constriction (g/ml)Absorbance at 269nmAbsorbance at 283nm50.1870.111100.3860.212150.5590.309200.7720.423250.9600.520301.120.650Table No.2 calibration data of montelukast.Concentration (g/ml)Absorbance at 269nmAbsorbance at 283nm20.0750.08860.2040.248100.3470.418140.5120.618180.6750.817220.7980.971Table No3 Results of analysis of tablet formulation. provokerLABEL CLAIM(mg/tablet)%LABELCLAIMMondeslorMontelukast(10mg) 100.4%Deslortadine(5mg) 101.%Table no4 Results of recovery studies doseAmount added (mcg/ml)Amount recovered (mcg/ml)% RecoveryDES80( 8)7.9699.5100(10)9.898120(12)12.2101.6MONT80(8)8.1101.2100(10)9.999120(12)11.898.5Table No5 Results of precision studies.DrugConcentration(g/ml)wavelengthAbsorbance%* RSDDES10269nm0.3820.3850.3870.6510283nm0.2140.2180.2160.9215269nm0.5600.5650. 5690.7915283nm0.3030.3080.3040.86DrugConcentration(g/ml)wavelengthAbsorbance%* RSDMON10283nm0.4130.4150.4180.6010269nm0.3480.3460.3490.4314269nm0.5100.5090.5120.2914283nm0.6130.6160.6180.40* mean of three observations Fig-1 survival of the fittest of wavelengthFig-2 Calibration curve of montelukastFig 3calibration curve of deslortadineREFERENCESFDA counsel for Industry. 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