Levocetrizine Dihydrochloride and Ambroxol Hydrochloride

Levocetrizine Dihydrochloride and Ambroxol HydrochlorideSIMULTANEOUS ESTIMATION OF LEVOCETRIZINE DIHYDROCHLORIDE AND AMBROXOL HYDROCHLORIDE IN SYRUP DOSAGE diversity BY USING UV SPECTROPHOTOMETRIC METHODS. S. Pekamwar, Madhav ShelkeABSTRACT A honest, economical, rapid, perfect and minute UV Spectrophotometric system acting was developed for simultaneous idea of Levocetrizine dihydrochloride and Ambroxol hydrochloride in bulk and in Syrup bodulation. Determination of Levocetrizine dihydrochloride (LCTZ) and Ambroxol hydrochloride (AMB) in bulk and in syrup was conducted by using simultaneous equation method establish on measurement of absorbance at 246 nm and 231 nm, max of LCTZ and AMB, respectively. The solvent employ for proposed method was methanol water (5050). The linearity for LCTZ and AMB was in the range of 5-35 g/ml and 5-50 g/ml, respectively. The developed method was validated as per ICH guidelines. The % retrieval was found to be in the range of 99.52- 99.82% an d 100.37- 100.72% for LCTZ and AMB, respectively. Thus the proposed method was simple, rapid, logical and accurate and can be successfully applied for simultaneous appraisal of Levocetrizine dihydrochloride and Ambroxol hydrochloride in bulk and in Syrup formulation.KEYWORDS Levocetrizine dihydrochloride, Ambroxol hydrochloride, coincident Equation Method, UV Spectrophotometry, Syrup, formation.INTRODUCTION Levocetirizine is a third generation non-sedative antihistamine. Chemically, levocetirizine is the busy enantiomer of cetirizine. It is the L-enantiomer of the cetirizine racemate. Levocetirizine works by blocking histamine receptors. Levocetrizine is chemically, (R)-2-2-4-(4- chlorophenyl)phenylmethyl piperazin-1-yl ethoxy acetic acid dihydrochloride.Chemical Structure of Levocetrizine dihydrochlorideAmbroxol is an active N-desmethyl metabolite of mucolytic bromhexine. Ambroxol is used as a bronchosecretolytic and expectorant dose. Ambroxol has been shown to increase the quantity and decline the viscosity of respiratory tract secretions. It enhances pulmonary surfactant production (surfactant activator) and stimulates cilial motility. These actions result in improved mucus flow and transport (mucociliary clearance). enhancement of fluid secretion and mucociliary clearance facilitates expectoration and eases cough. Ambroxol is chemically, trans-4-(2-Amino-3,5-dibromobenzyl)amino cyclohexanol hydrochloride.Chemical Structure of Ambroxol hydrochloride literature survey revealed that various analytical methods involving UV Spectrophotometry, HPLC and HPTLC have been reported for LCTZ and AMB exclusively and in Combination with other drugs. However there is no method developed for simultaneous estimation of Levocetrizine dihydrochloride and Ambroxol hydrochloride in liquified dosage form (Syrup). The objective of stupefy work was to develop simple, rapid, economical accurate and precise analytical method for simultaneous estimation of Levocetrizine dihydrochloride and Ambroxol hydrochloride in bulk and in liquid dosage form (Syrup). The developed method was validated in accordance with ICH guidelines and successfully employed for the balk of LCTZ and AMB in combined liquid dosage form (Syrup).MATERIALS AND METHODSChemicals and Reagents Analytically, pure LCTZ and AMB were provided as gift sample by Bidwai Chemicals Pvt. Ltd. Nanded and Glen crown of thorns pharmaceutics, Mumbai, Maharashtra, respectively. Syrup of LCTZ and AMB, Mzic D manufactured by Monad Pharmaceuticals, were purchased from local pharmacy. wood alcohol AR grade (Molychem) and Distilled water was used throughout the experimental work.Instruments A UV-Visible Spectrophotometer Shimadzu, Model UV-1800 with 1 cm matched quartz cell and UV dig into 2.33 software was used. Calibrated analytical balance Anamed was used for weighing purpose. digital Ultrasonic Cleaner (Sonicator) HMG India and Vaccum Pump Assembly Millipore was used for the experimental work. zeal Standard Stock SolutionAmbroxol hydrochloridre standard bear solventaccurately weighed reference standard of AMB (10mg) was transferred to 100ml volumetric flask and turn in 50 ml solvent (Water, methanol 11) and sonicate for 5 min. then volumes was do up to the mark with same solvent to obligate standard shoot solution (100g/ml) of drug. For the preparation of working standards, suitable aliquots of short letter solution were pipette out and volumes were made up to the mark with solvent (Water, methanol 11) so as to get undeniable concentrations.Levocetrizine dihydrochloride standard seam solutionAccurately weighed reference standard of LCTZ (10mg) was transferred to 100ml volumetric flask and dissolved in 50 ml solvent (Water, methanol 11) and sonicated for 5 min. then volumes was made up to the mark with same solvent to obtain standard stock solution (100g/ml) of drug. For the preparation of working standards, suitable aliquots of stock solution were pipette out and vo lumes were made up to the mark with solvent (Water, methanol 11) so as to get required concentrations.Selection of analytical wavelengthSample solutions were scanned over the wavelength range of 200 nm to 400 nm, max for AMB and LCTZ were found at 231 nm and 246 nm. Representative submersion spectra of AMB and LCTZ are shown in fig. 1 2.Fig. 1 submerging Spectra of LCTZFig. 2 Absorption spectra of AMBPreparation of calibration curve of AMB and LCTZBy appropriate dilution of standard stock solution, different dilutions were prepared ranging from 5g/ml to 35g/ml for LCTZ and 5 g/ml to 50 g/ml for AMB. Absorbance of all the dilutions was plotted against the respective concentrations to obtain the calibration curves. The absorption overlain spectrum of AMB and LCTZ is shown in fig. 3Fig. 3 Overlay Spectra of LCTZ AMBFig. 4 Calibration Curve of LCTZFig. 5 Calibration Curve of AMBAnalysis of Marketed Syrup nisusulationTen syrup bottles were weighed accurately, average weight was determined and poured in calibrated measuring cylinder to check extractable volume. As per label claim syrup post LCTZ 5mg/5ml and AMB 30mg/5ml, so 5ml syrup was pipette out in 100 ml volumetric flask and dissolved in water methanol (11) solution, sonicated for 10 min and filtered. Then different concentrations of syrup sample were prepared by serial dilution method and used for analysis. Prepared syrup sample was analysed on UV spectrophotometer using coincident Equation Method.Method ValidationThe method governance parameters linearity, precision, accuracy, repeatability, limit of detection and limit of quantitation were checked as per ICH guidelines.preciseness Precision of the method was verified by using syrup stock solution, the repeatability indicates the performance of the UV instrument. Interday and intraday precision was determined by repeating the assay three times in same day for intraday precision and on different day for interday precision studies.Accuracy (Recove ry Study) To check the accuracy of proposed method, convalescence studies were carried out at 80%, 100% and long hundred% of the test conc. As per ICH guidelines.To perform convalescence study at 100%, 5ml syrup pipette out in volumetric flask and to this standard 30mg AMB and 5mg LCTZ was added. The volume as made up to the mark with water methanol (11) solution and advertize dilution with same solvent to obtain sample solution Similarly, for 80% recovery study, 26mg AMB and 4mg LCTZ were added, and for 120% recovery study, 36mg AMB and 6mg LCTZ were added respectively.RESULTS AND DISCUSSIONPrecisionIntraday PrecisionSr. noInterval ofConcentration (g/ml)% RecoveryTimeAMBLCTZI30.104.96100.3499.35IIIntra-day29.954.9599.8499.28III30.204.97100.6899.54 tabularise 1 Intra-day Precision data of marketed formulation light upon of the drugMean*SD%RSDAMB100.280.42250.4213LCTZ99.400.13450.1353* Indicates average of three determinationsTable no 2 Statistical validation of intra-day pre cision dataInter-day PrecisionSr. No.Interval ofConcentration (g/ml)% RecoveryTimeAMBLCTZAMBLCTZI30.144.98100.4599.79IIInter-day30.094.98100.3299.72III29.964.9899.8799.63Table 3 Inter-day Precision DataName of the drugMean*SD%RSDAMB100.210.30430.3036LCTZ99.710.08020.0804* Indicates average of three determinationsTable 4 Statistical validation of inter-day precision dataAccuracy (Recovery study) take aim of RecoveryAmount present(mg/5ml)Added concentration (mg)Amount recovered(mg)% RecoveryAMBLCTZAMBLCTZAMBLCTZAMBLCTZ30524454.318.97100.5899.7480%30524454.208.95100.3899.5230524454.388.98100.7299.8230530560.289.96100.4799.68100%30530560.329.97100.5499.7030530560.229.95100.3899.5430536666.3110.96100.4899.69120%30536666.3610.96100.5699.7230536666.2410.95100.3799.58Table 5 Recovery study dataLevel ofrecovery% Mean recoveryS.D.% R.S.D.AMBLCTZAMBLCTZAMBLCTZ80%100.5699.700.17080.15530.16980.1557100%100.4699.640.08020.08710.07980.0874120%100.4799.670.09530.07370.09480.0951Table 6 Statisti cal validation of recovery study data resile of Detection and Limit of QuantitationName of the drugLOD g/mlLOQ g/mlAMB3.16459.5896LCTZ3.08919.3611Table 7 LOD LOQCONCLUSIONThe method used is simple and rapid and does not involve the use of complex instrument, low nourish of Standard deviation showed that the method is precise and high percentage of recovery of as shown in table shows that the method is accurate. 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