ROSUVASTATIN AND ASPIRIN COMBINATION

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APMC COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH

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DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ROSUVASTATIN AND ASPIRIN IN PHARMACEUTICAL DOSAGE FORM . DEPARTMENT OF QUALITY ASSURANCE APMC college of Pharmaceutical Educations and Research Himatnagar Guided by: Mr. Ashok Mahajan Assistant Professor 2011-2012 Prepared By:- Dhiren S.Patel M.Pharm Sem III Enrollment no:102070804017

CONTENTS:

Introduction Drug profile Literature review Aim of work Plan of work References CONTENTS

INTRODUCTION :

INTRODUCTION TO HYPERLIPIDEMIA Hyperlipidemia is an excess of fatty substances called lipids, largely cholesterol and triglycerides , in the blood. It is also called hyperlipoproteinemia. Hyperlipidemia, in general, can be divided into two subcategories: Hypercholesterolemia , in which there is a high level of cholesterol. Hypertriglyceridemia , in which there is a high level of triglycerides, the most common form of fat. INTRODUCTION

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INTRODUCTION TO UV SPECTROPHOTOMETRIC METHOD Simultaneous equation method Absorbance ratio method Difference spectrophotometry Derivative spectrophotometry Geometric correction method Orthogonal polynomial method

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INTRODUCTION TO HPLC METHOD Various components of HPLC are: A solvent delivery system, including pump Sample injection system A chromatographic column A detector A strip chart recorder Data handling device and microprocessor control.

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INTRODUCTION TO VALIDATION OF ANALYTICAL METHODS USP/ICH (23)

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DRUG PROFILE Rosuvastatin is HMG- CoA reductase inhibitor. (1) Structural Formula Chemical Name Rosuvastatin Calcium is ( E)-(3R,5S)-7-{4-(4-fluorophenyl)-6- isopropyl-2{methyl( methylsulphonyl amino)] pyrimidin-5-yl }-3,5-dihydroxyhepten-6-oic acid calcium. Empirical Formula: C 22 H 27 FN 3 O 6 S.Ca Molecular Weight: 1001.14 gm/mol Melting point : 155°C Solubility : soluble in Acetonitrile and alcohol ,slightly soluble in Acetone . Wavelength : 244 nm in methanol Molar absorptivity: 4.3×10 4 L/mol.cm

Aspirin is Anti-Inflammatory Agents(2,20) :

Empirical Formula: C 9 H 8 O 4 Molecular Weight: 180.2 gm/mol Melting point : 137°C Solubility : Freely soluble in alcohol;soluble in chloroform and in ether; slightly soluble in water . Molar absorptivity : 5.92 × 10 4 L/mol.cm Aspirin is Anti-Inflammatory Agents (2,20) Structural Formula Chemical Name: 2-acetoxybenzoic acid . Wavelength : 266 nm in methanol

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Method Description Ref No. Assay by Official method liquid chromatography Mobile phase : 0.2% acetic acid in water : acetonitrile : methanol)(50:25:25). Flow rate: 1 ml per minute. Wavelength: 248 nm 1 Estimation by Non official method UV Spectrophometric method Solvent: methanol • Linearity Range : 2-18 μ g/ mL • Working solution diluted with methanol • Wavelength : 244 nm 6 Rosuvastatin is official in IP 2007. LITERATURE REVIEW

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Method Description Ref. No. UV spectrophotometric method ( Simultaneous Equation Method ) • Solvent: methanol • Linearity Range : 5-25 μg/ml. • Working solution diluted with methanol • Wavelength : 244nm 7 UV spectrophotometric method ( Simultaneous Equation Method ) • Solvent: methanol • Linearity Range : 5-40 μg/ml. • Working solution diluted with methanol • Wavelength : 243.60 nm 8 RP-High performance liquid chromatography • Column: C18 150 x 4.6 mm • mobile phase: 0.05 M phosphate buffer (pH 2.5)-Methanol (45+55, v/v). • flow rate :1.0 mL min-1 • Wavelength: 242 nm 9 High performance thin l ayer chromatography(HPTLC) method • S tationary phase: aluminium plates coated with silica gel 60 F254. • M obile phase: Ethyl Acetate : Toluene : Methanol (6 : 2 : 2, v/v/v) • Wavelength: 254 nm 10

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Method Description Ref. No. UV Sp e c t r o ph o m e t ri c m et h od (Extractivespectrophotometric method) • Solvent : methanol • Linea r i t y Ra ng e : 5 -25 μ g/ ml . • Wor ki ng s ol u t io n dil u te d with m etha no l • W a v e l e n g t h : 518 n m 15 UV spectrophotometric method • Solvent: methanol • Linea r i t y Ra ng e : 5 -25 μ g/ ml . • Wor ki ng s ol u t io n dil u te d with m etha no l • . W a v e l e ngt h : 244n m 16 Hig h performanc e liquid chromatography • Column: C 18 co l umn (250× 4.6mm , particle size 5μm) • Mobie phase:Methanol : 0.02M ammoniu m d i hydrogen phosphate buffer (75:25v/v, PH 5 . 5 adjustedwi t h ortho phosphoric acid) • flow rate : 1.0 ml /m in. • Wavelength: 272 n m 17

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Method Description Ref. No. RP-High performance liquid chromatography • Column: C - 18, 5 μ m column having 100 x 4.6 m m i.d . • Mobilephase:Acetonitrile:Potassium di h ydr o gen orthophosp h ate (5 0 : 50 v v, pH 3) . • flow rate : 0.5 ml / m in. • Wavelength:243 n m 18 RP-High performanc e liquid chromatography • Column: C 18, 5 μ m 4.6 m m ×250 mm colum n . • mobil e phase:buffe r (p H 4.5): Acetonitrile: methanol ( 4 5 : 25:35). • flow rate : 1.0 ml /m in. • Wavelength: 248 n m 19

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RP-High performance liquid chromatography • Column:(Inertsil ODS, 250 x 4.6mm , 5μ co l umn). • Mobile phase: Water ( pH adju s t ed to 2.5 with ortho phosphoric acid) an d a cetonitrile in ratio (30 : 7 0 v/v). • flow rate : 1.0ml/ m in. • Wavelength: 248 n m 19

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Method Description Ref No. Assay by Official method Titrimetric method • Weigh accurately about 1.5 g, dissolve in 15 ml of ethanol (95 per cent), add 50.0 ml of 0.5 M sodium hydroxide, boil gently for 10 minutes, cool. • Titrate: 0.5 M hydrochloric acid . • Indicator :phenol red solution. 2 Estimation by Non official method UV Spectrophotometric method. (zero-order and D erivative spectrophotometric) • Solvent: 0.1M HCL • Linearity Range : 4–28 μg/ml • Wavelength : 210–305 nm 11 Aspirin is official in IP 2007.

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Method Description Ref. No. UV Spectrophotometric method. (Second order derivative spectroscopy method) • Solvent: Methanol • Linearity Range: 4-12μg/ml • Working solution diluted with methanol • Wavelength : 266.78 nm 12 UV spectrophotometric method ( Simultaneous Equation Method ) • Solvent: 0.1 N HCl: methanol (1:1) • Linearity Range : 2 to 64 μg/ml • Working solution diluted with methanol • Wavelength : 265 nm 13 RP-High performance liquid chromatography • Column: C-18. • Mobile phase: using Methanol and Acetate buffer [pH adjusted to 3.1 with Orthophosphoric acid (dil.)] in the ratio (70:30v/v). • Flow rate: 3.04 ± 0.15 min 14

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Method Description Ref. No. Hig h p erf o rmanc e liquid chromatograp h y • colum n : H ypersil BDS C18 (100 x 4.6 mm 5 μ ). • mobi l e phas e : sod i u m perchlorate buffer (pH 2.5): acetoni t rile:isopro p yl alcohol (85:14:1 % v/v) . • flow rate :1.5 ml m i n-1 . • Wavelength: 275 n m 21 RP-Hig h perf o rmance liquid chromatograp h y • Column: C18 column(250mm × 4mm i.d .,5 μ m ) . • Mobile Phase:acetonitrile:0.01M TBAHS • flow rate : 1.0ml/ mi n. • Wavelength:240nm 22 Deep literature survey reveals that, not a single analytical method is reported for the determination of these drugs in combined dosage forms

AIM OF WORK:

ROSUVASTATIN (10 mg) in combination with ASPIRIN (75 mg) capsule is approved for marketing in India from March 2011 for the treatment of Hyperlipidemia So it was thought of interest to develop and validate simple, sensitive, specific, accurate, precise and economical analytical methods for the estimation of these two drugs in combined dosage forms. AIM OF WORK To carry out spectrometric determination by following techniques: 1.UV-Visible spectrophotometry and/or 2.Reversed Phase HPLC

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PLAN OF WORK

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REFERENCES “Indian Pharmacopoeia”.Volume III, The Indian Pharmacopoeia Commission,Ghaziabad, Govt. of India Ministry of Health and Family Welfare 2007; pp. 1676-1677. “Indian Pharmacopoeia”. Volume II, The Indian Pharmacopoeia Commission,Ghaziabad, Govt. of India Ministry of Health and Family Welfare 2007; pp. 745. Beckett A.H, Stenlake J.B,UV-visible Spectrophotometry: “Practical PharmaceuticalChemistry” , 4th ed., Part-II, C.B.S. Publishers, Delhi, 2001, pp. 285-297.

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Beckett A.H, Stenlake J.B,UV-visible Spectrophotometry: “Practical PharmaceuticalChemistry” , 4th ed., Part-II, C.B.S. Publishers, Delhi, 2001, pp. 285-297. Skoog D.A et al., “Introduction to UV Spectroscopy in, Principle of instrumental analysis” Fifth edition, Thomson Brooks/Cole publication, pp. 301, 893-934.

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Gupta A,Mishra P.and,Shah K.., “ Simple UV Spectrophotometric Determination of Rosuvastatin Calcium in Pure Form and in Pharmaceutical Formulations .” E-Journal of Chemistry http://www.e-journals.net . 2009 , 6(1), 89-92 . Sevda.R.R.,Ravetkar.A.S.,Shirote.P.J.“UV Spectrophotometric estimation of Rosuvastatin Calcium and Fenofibrate in bulk Drug and Dosage Form using Simultaneous Equation Method”. International Journal of ChemTech Research . April-June 2011 , 3 ( 2 ) ,629-635 . Pandya C.B.,Channabasavaraj K.P., Shridhara H S., “Simultaneous Estimation of Rosuvastatin Calcium and Ezetimibe in Bulk and Tablet Dosage Form by Simultaneous Equation Method”. International Journal of ChemTe ch Research . Oct-Dec 2010 , 2 ( 4 ) , 2140-2144 .

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Gajjar A.K., and. Shah V.D.,“Development and Validation of a Stability- Indicating Reversed-Phase HPLC Method for Simultaneous Estimation of Rosuvastatin and Ezetimibe from Their Combination Dosage Forms”. Eurasian J. Anal. Chem. 2010 , 5(3) , 280-298. Devi.S.U,Latha.E.P*,Nagendra.C.V.,Guptha .K and Mr. Ramalingam .P., “Development and validation of hptlc method for estimation of rosuvastatin calcium in bulk and pharmaceutical dosage forms”. International Journal of Pharma and Bio Sciences . Apr-Jun 2011 ,2(2), 134-140. Abdil Özdemir, Erdal Dinç, Feyyaz Onur. “Utilization of multivariate calibration techniques for the spectrophotometric simultaneous determination of paracetamol, aspirin and caffeine in a pharmaceutical formulation”, Turkish J. Pharm. Sci . 2004 , 1(3),139-151 .

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Patel G. F, Vekariya N. R., Dholakiya R. B, “Estimation of Aspirin and Atorvastatin Calcium in Combine Dosage Form Using Derivative Spectrophotometric Method” . International Journal of Pharmaceutical Research . 2010 , 2(1), 62-66. Murtaza G., Khan S .A., Shabbir A., Mahmood A., Muhammad Hassham Hassan Bin Asad, Farzana K., Malik N S and Hussain I., “Development of a UV-spectrophotometric method for the simultaneous determination of aspirin and paracetamol in tablets” . Scientific Research and Essays . 2011 , 6(2), 417-421. S.M.Patole, L.V.Potale, A.S.Khodke, M.C.Damle, “A validated HPLC method for analysis of atorvastatin calcium, ramipril and aspirin as the bulk drug and in combined capsule dosage forms” . International Journal of Pharmaceutical Sciences Review and Research . September – October 2010 ,4(3) 40-45 .

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Prajapati P.B,,Bodiwala K.B.,Marolia B.P.,Rathod I.S.,Shah S.A. “Development and Validation of Extractive spectrophotometric method for determination of Rosuvastatin calcium in pharmaceutical dosage forms.” Journal of Pharmacy Research. 2010, 3(8),2036-2038. Sevda.R.R.,Ravetkar.A.S.,Shirote.P.J .“UV Spectrophotometric estimation of Rosuvastatin Calcium and Fenofibrate in bulk Drug and Dosage Form using Simultaneous Equation Method ”. International Journal of ChemTech Research. April- June 2011,3(2),629-635. Devika.G.S,.Sudhakar .M., and Rao J.V.,“A new improved rp-hplc method for simultaneous estimation of rosuvastatin calcium and fenofibrate in tablets”. International Journal of Pharmacy and Pharmaceutical Sciences. 2011,3(4),311- 315.

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Pandya C.B., Channabasavaraj K.P., Chudasama J.D., Mani T.T.,“Development and validation of RP-HPLC method for determination of Rosuvastatin calcium in bulk and pharmaceutical dosage form”. International Journal of Pharmaceutical Sciences Review and Research.November – December 2010,5(1),82-86. Suresh Kumar GV, Rajendraprasad Y. “Development and Validation of Reversed- PhaseHPLC Method for Simultaneous Estimation of Rosuvastatin and Fenofibrate in Tablet Dosage Form”. International Journal of PharmTech Research, July-Sept 2010, 2(3),2016-2021. Florey ,“Analytical Profile of Drug Substances”,vol-8 Published by Elsevier,pp.8.

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Suresh Kumar S., Latif D.Jamadar *, Krishnamurthy Bhat , Prashant B. Musmade,S.G.Vasantharaju , N.Udupa,“Analytical method development and validation for aspirin”. International Journal of ChemTech Research. Jan-Mar 2010,2(1)389-399. Panda S S.,“Ion -Pairing RP-HPLC Method for Simultaneous determination ofAspirin and Clopidogrel bisulphate in Tablet and Capsule Dosage Form”. International Journal of PharmTech Research. Jan-Mar 2010,2(1),269-273. ICH Harmonized Tripartite Guideline, ICH Q2A, Text on Validation of Analytical Procedures, Mar. 1995

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