The current work was carried out for estimation of labetalol hydrochloride in bulk and pharmaceutical dosage form by utilizing area under curve method (AUC) method .For this purpose the wavelength range 200-400 nm was selected .Distilled Water was used as a solvent throughout the work. The linearity was observed in concentration range 5-25 µg/ml (r2 =0.9788) for the method. The present was found which can be used for routine quality control analysis for spectrophotometric estimation of labetalol hydrochloride in bulk and dosage form.
Keywords: Labetalol hydrochloride, Area under curve (AUC), Distilled Water, UV Spectrophotometric

Abhang, Suchita R.

Dhobale, Shankar M.

Patel, Salim G.

Suryawanshi, Akshada D.

Journal of Drug Delivery and Therapeutics (JDDT)

Suryawanshi et al                                                                                                  Journal of Drug Delivery & Therapeutics. 2019; 9(3):168-170 ISSN: 2250-1177                                                                                  [168]                                                                                 CODEN (USA): JDDTAO Available online on 15.05.2019 at http://jddtonline.info Journal of Drug Delivery and Therapeutics Open Access to Pharmaceutical and Medical Research © 2011-18, publisher and licensee JDDT, This is an Open Access article which permits unrestricted non-commercial use, provided the original work is properly cited Open  Access                                                                                                                                                     Research Article Estimation of Labetalol Hydrochloride in bulk and formulation by UV-Spectrophotometric Area Under Curve. Akshada D. Suryawanshi*, Shankar M. Dhobale, Suchita R. Abhang, Salim G. Patel Vishal Institute of Pharmaceutical Education and Research, Ale, Tal- Junnar, Pune (412411) Maharashtra, India  ABSTRACT The current work was carried out for estimation of labetalol hydrochloride in bulk and pharmaceutical dosage form by utilizing area under curve method (AUC) method .For this purpose the wavelength range 200-400 nm was selected .Distilled Water was used as a solvent throughout the work. The linearity was observed in concentration range 5-25 µg/ml (r2 =0.9788) for the method. The present was found which can be used for routine quality control analysis for spectrophotometric estimation of labetalol hydrochloride in bulk and dosage form. Keywords: Labetalol hydrochloride, Area under curve (AUC), Distilled Water, UV Spectrophotometric.   Article Info: Received 24 March 2019;     Review Completed 30 April 2019;     Accepted 02 May 2019;     Available online 15 May 2019 Cite this article as: Suryawanshi AD, Dr. Dhobale SM, Abhang SR, Patel SG, Estimation of Labetalol Hydrochloride in bulk and formulation by UV-Spectrophotometric Area Under Curve., Journal of Drug Delivery and Therapeutics. 2019; 9(3):168-170    http://dx.doi.org/10.22270/jddt.v9i3.2633                   *Address for Correspondence:  Ms. Akshada D. Suryawanshi, Department of M.Q.A., Vishal Institute of Pharmaceutical Education and Research, Ale, Tal- Junnar,  Dist- Pune (412411) Maharashtra, India.   INTRODUCTION Labetalol is used with or without other medications to treat high blood pressure (hypertension). Labetalol Hydrochloride is the hydrochloride form of labetalol, a third generation selective alpha-1-adrenergic antagonist and non-selective beta-adrenergic antagonist with vasodilatory and antihypertensive properties. Labetalol competitively binds to alpha-1-adrenergic receptors in vascular smooth muscle, thereby inhibiting the adrenergic stimulation of endothelial cell function and vasoconstriction in peripheral blood vessels. This agent also binds to beta-receptors in the bronchial and vascular smooth muscle, resulting in a decrease in adrenergic stimulation. The result is a decrease in resting and exercise heart rates, cardiac output, and in both systolic and diastolic blood pressure, thereby resulting in vasodilation, and negative chronotropic and inotropic cardiac effects. Chemically is 2-hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide;hydrochloride.1,2  Figure 1  :Chemical Structure of labetalol hydrochloride. MATERIALS AND METHOD 1.Chemicals : Labetalol hydrochloride was a gift sample from Flamingo Pharmaceutical, Taloja, Navi Mumbai, India. Labetalol Hydrochloride 100 mg MACLEODS. All chemicals and reagents were of analytical (AR) grade. 2.Instrumentation:  A Shimadzu (Kyoto , Japan )model UV – 1800 double beam UV – Visible spectrophotometer attached with computer operated software UV probe 2.33 with spectral width of 2 nm, wavelength accuracy of 0.5 nm and pair of 1 cm matched quartz cells was used to measure absorbance of the resulting solutions . Analytical balance and mattler Toledo (Model JL1503–C). 3.METHOD:  A) UV-Spectroscopy Methods: a)Area under curve method : The AUC (area under curve) method is applicable where there is no sharp peak or when broad spectra are obtained. It involves the calculation of integrated value of absorbance with respect to the wavelength between the two selected wavelengths λ1 and λ2. Area calculation processing item calculates the area bound by the curve and the horizontal axis. The horizontal axis is selected by entering the wavelength range over which area has to be calculated. This wavelength range is selected on the basis of repeated Suryawanshi et al                                                                                                  Journal of Drug Delivery & Therapeutics. 2019; 9(3):168-170 ISSN: 2250-1177                                                                                  [169]                                                                                 CODEN (USA): JDDTAO observation so as to get the linearity between area under curve and concentration. The above-mentioned spectrums were used to calculate AUC. 3 4.  Experimental Work:  a) To check the solubility of Labetalol Hydrochloride:  10 mg of Labetalol Hydrochloride was weighed and solubility of this sample was checked in distilled water, methanol, 1N NaOH.  b) To identify the λmax of Labetalol Hydrochloride:  Accurately weigh 100 mg of pure drug and dissolve it in a small portion of distilled water and makeup the final volume up to 100 ml using distilled water to give a standard stock solution of 1000 µg/ml. From above solution withdraw 10 ml solution and transfer it into a 100 ml volumetric flask and makeup final volume with distilled water to prepare 100 µg/ml solution. Suitable dilutions made with distilled water to get working standard solutions of 5, 10, 15, 20, 25µg/ml.4 Spectrum peak details are shown in Fig 2 spectrum peak pick . C) Sample preparation for analysis of formulation: Accurately weigh twenty tablets of metformin crush the tablets and measure the weight of powder equivalent to 100 mg of drug. Then transfer it into a 100ml volumetric flask dissolve it into distilled water properly and make up the final volume with same distilled water to prepare 1000 µg/ml solution. Then it filtered through whatman filter paper, pippetout 10ml filtrate transfer it into 100 ml volumetric flask and makeup the volume up to 100 ml with distilled water to prepare 100 µg/ml solution. Suitable dilutions made with distilled water to get working standards of 5, 10, 15, 20, 25 µg/ml.5,6 5.  Analytical Method Development and Validation:  The developed method was validated as per ICH guidelines.  1) Linearity:  The linearity of an analytical procedure is the interval between the upper and lower concentration of an analyte in the sample.For which it has been demonstrated that the analytical procedure is of linearity. Standard solution of Labetalol hydrochloride (5,10,15,20,25μg/ml) was pipette out in to a separated series of 25ml volumetric flask. The volume was adjusted to the mark with distilled water and mixed well. 7,8 The absorbance maxima and area under curve for the solutions was measured at 219.20nm and range of 200-400nm for two methods respectively against distilled water as blank. RESULTS AND DISCUSSION 1. λmax of Labetalol Hydrochloride  Figure 2: Spectrum Peak Report of Labetalol 2. Linearity & Range:  A] Calibration curve for pure drug:  a) Absorbance maxima method:  Under the experimental conditions described, the graph obtained for the absorbance maxima for pure drug showed linear relationship (Fig.2).Regression analysis was made for the slope, intercept and correlation-coefficient values. The regression equations of calibration curve were y=0.0517x +0.2567(R2=0.9788) at 219.20 nm for absorption maxima the range was found to be 5-25μg/ml for the UV spectrometry. Table 1: Calibration curve of Labetalol hydrochloride. CONC. ABS 5 0.444 10 0.868 15 1.039 20 1.279 25 1.531   Figure 3: Calibration of Labetalol Hydrochoride (Pure Drug). Table.2:Calibration curve of Labetamac. Conc. Abs. 5 0.389 10 0.871 15 1.225 20 1.55 25 1.796   Figure 4: Calibration of formulation of Labetalol hydrochoride (Labetamac). y = 0.0517x + 0.2567 R² = 0.9788 00.511.520 10 20 30abs absLinear (abs)Conc abs y = 0.0699x + 0.1183 R² = 0.9851 00.511.520 5 10 15 20 25 30abs absLinear (abs)CONC ABS Suryawanshi et al                                                                                                  Journal of Drug Delivery & Therapeutics. 2019; 9(3):168-170 ISSN: 2250-1177                                                                                  [170]                                                                                 CODEN (USA): JDDTAO b) Area under curve method:  Under the experimental conditions described, the graph obtained for area under curve spectra showed linear relationship (Fig.3& Fig.4).  The range was found to be 5-25μg/ml for area under curve spectrophotometric analysis.9  Fig 5 : Area between 212.60-226.40nm selected for Labetalol hydrochloride.  Fig 6: Area between 211.00-223.80nm selected for Labetamac.  CONCLUSION Simple UV spectrophotometric methods have been developed and validated for the determination of Labetalol hydrochloride bulk and formulation.  Because of cost-effective and minimal maintenance, the present UV spectrophotometric methods can be preferred at small scale industries and successfully applied and suggested for the quantitative analysis of labetalol hydrochloride in pharmaceutical formulations for QC, where economy and time are essential and to assure therapeutic efficacy. ACKNOWLEDGEMENT The author are thankful acknowledge to Dr. Dhobale S.M., Head of Pharmaceutics Department Vishal Institute of Pharmaceutical Education and Research, Ale, Pune for constant motivation and encouragement and also providing  Labetalol Hydrochloride drug as a gift sample  from Flamingo Pharmaceuticals, Taloja, Navi Mumbai, India, For research work. We would like to thank our principle Dr. Jadhav S.L for providing us suitable environment for this work.  REFERENCES 1) https://pubchem.ncbi.nlm.nih.gov/compound/Labetalol_hydrochloride. 2) https://en.wikipedia.org/wiki/Labetalol 3) Michael E. Swartz, Ira S. Krull, Analytical method development and validation, Marcel Dekker, Inc., 1997; 17: 25-2.  4)  Christian G.D, John Wiley and Sons, Analytical chemistry, sixth edition 2003; 1-2,604- 620.  5) Beckett, A. H., Stenlake, J. B., Practical Pharmaceutical Chemistry, 4th edition, CBS Publishers and Distributors, New Delhi, 2002; 2: 275-295.  6) Saravanan V, Revathi R, Meera N, Method Development and Validation for the Simultaneous Estimation of Lycopene and Ubidecarenone By RP-HPLC in Combined Pharmaceutical Dosage Form. Journal of Drug Delivery and Therapeutics, 2016; 6(5):46-51.  7) ICH Harmonised Tripartite Guideline: Validation of analytical procedures: text and methodology Q2 (R1).  8) Pachpute  Karishma  and Jadhav S.L, Estimation  of Disulfiram in Bulk and Formulation by UV- Spectrophotometric Area Under Curve method, Inventi Rpid:Pharma Analyis & Quality Assurance 2019; 2. 9) Chordiya Bhakti, Patel S G, Dhobale S M. Estimation of Pazufloxacin Mesylate in bulk and formulation by UV- Spectrophotometric area under Curve Method, Int. Ref. J. of Science and Enginerring, 2018 A3:193-198   

Estimation of Labetalol Hydrochloride in bulk and formulation by UV-Spectrophotometric Area Under Curve.

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Estimation of Labetalol Hydrochloride in bulk and formulation by UV-Spectrophotometric Area Under Curve.

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