ESTIMATION OF LORCASERINE HYDROCHLORIDE IN TABLET DOSAGE FORM AND IN BULK DRUG BY SPECTROPHOTOMETRIC METHOD

DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

BY

DAYANANDA.V

M.PHARM, PART-1

DEPARTMENT OF QUALITY ASSURANCE

M.M.U. COLLEGE OF PHARMACY

RAMANAGARAM-562159

KARNATAKA

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE-560041 KARNATAKA,

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS) / DAYANANDA.V
S/O VENKATESH.
#197, OLD MILK DAIRY ROAD
KATARIPALYA
KOLAR-563101
2. / NAME OF THE INSTITUTION / M.M.U COLLEGE OF PHARMACY
K.K DODDI, RAMADEVERA BETTA ROAD RAMANAGARAM-562159
KARNATAKA
3. /

COURSE OF STUDY AND SUBJECT

/ MASTER OF PHARMACY IN
QUALITY ASSURANCE
4. / DATE OF ADMISSION OF COURSE / 28-05-2012
5. /

TITLE OF TOPIC

/ ESTIMATION OF LORCASERINE HYDROCHLORIDE IN TABLET DOSAGE FORM AND IN BULK DRUG BY SPECTROPHOTOMETRIC METHOD
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 Need for the study
6.2 Review of the literature
6.3 Objectives of the study / ENCLOSURE-I
ENCLOSURE-II
ENCLOSURE-III
7. /

MATERIALS AND METHODS

7.1 Source of data
7.2 Method of collection of data
7.3 Does study require any Investigations or interventions to be conducted on patients or Other human or animal? If so, Please describe briefly.
7.4 Has ethical clearance been obtained from your institution in case of
7.3. / ENCLOSURE-IV
ENCLOSURE-V
ENCLOSURE-VI
ENCLOSURE-VI
8. / LIST OF REFERENCES / ENCLOSURE-VII
9. / SIGNATURE OF CANDIDATE / (DAYANANDA.V)
10. / REMARKS OF GUIDE / RECOMMENDED FOR THE DISSERTATION WORK
11 / NAME AND DESIGNATION OF
11.1 Guide
11.2 Signature of guide
11.3 Co-guide (if any)
11.4 Signature of co-guide
11.5 Head of department
11.6 Signature of head of department / PROF. MOHAMMED KHALEEL (QUALITY ASSURANCE)
M.M.U COLLEGE OF PHARMACY
K.K DODDI, RAMADEVERA BETTA ROAD RAMANAGARAM-562159
KARNATAKA
Not applicable
Not applicable
PROF. NIRMAL.T. HAVANNAVAR HEAD OF THE DEPARTMENT (QUALITY ASSURANCE)
M.M.U COLLEGE OF PHARMACY
K.K DODDI, RAMADEVERA BETTA ROAD, RAMANAGARAM-562159
KARNATAKA STATE
12. / 12.1 Remarks of the
Chairman and principal
12.2 Signature / FORWARDED AND RECOMMENDED FOR FAVOURABLE CONSIDERATION
(PROF. MOHAMED KHALEEL)
6. BRIEF RESUME OF THE INTENDED WORK
ENCLOSURE-I
6.1 Need for the study
Spectrophotometric method is widely used in the analytical techniques for quantitative analysis of pharmaceutical dosage forms, biomolecules and organic compounds. It is very simple and sensitive and inexpensive method of analysis.
Lorcaserine hydrochloride tablet is a weight-loss drug. It has serotonergic properties and act as anorectic. The estimation and evaluation of these types of drugs holds importance as there is a lot of side effect associated with tablet dosage form. It is necessary to examine the amount of therapeutic active compounds in tablet dosage form. Since the molecule is new, newer estimation method is to be developed for the evaluation of the Lorcaserine hydrochloride.
ENCLOSURE II
6.2 Review of literature
1.  M. Mathrusri. Aetal. they developed different spectrophotometric method to estimate the bosentan in pharmaceutical dosage form. They describe the estimation by three methods, the method A is based on the bosentan observed at ( λmax ) 269 nm. It obeys the beer-Lambert’s law in the range of 1-120µg/ml. Method B is based on the first derivative method. Method C is based on area under curve method of determination.
2.  Hemanth K. A et al. established that the spectrophotometric method is simple and reliable method to estimate drugs in pharmaceutical products are needed in the most care. anti-retroviral drugs estimation are performed by HPLC method required expencive equipments and train technician compare to spectophotometric method.
3.  Willard.M. A et al. developed a spectrophotometric method for determination of pyrimethamine obsorbing at the 272 nm. And pseudoephidrine is obsorbing at 258 nm. Both the compounds are structurally related to phenyramidol HCl.
4.  JackW.W.Aetal. developed differential method in biological specimen ephedrine and certain related compounds in the procedure compound is oxidized by means of alkaline peroxide and estimate the oxidizing drugs.
5.  Adhikari. L. A et al. they developed two simple and sensitive specrophotometric method in UV region and Visible region were developed for the estimation of Nitazoxanide in its pharmaceutical dosage forms. Method A is based on Nitazoxanide showing its obsorption maxima at 238.3 nm in acetonitrile and water (9:1) The method B is based on the reaction of Nitazoxanide with 1ml of 1% ferric chloride and 2ml of 0.1% MBTH to produse green colour.
6.  Pradeep mishra, Kamal shah A et al. developed simultaneous estimation of Nebivolol hydrochloride and Amlodipine besylate in tablet dosage form. The proposed methods were based on the partial simultaneous equation method, using methanol as solvent. Nebivolol hydrochloride has absorbance maxima at 281 nm and Amlodipine besylate at 238 and 360 nm. As Nebivolol hydrochloride shows zero absorbency at 238 nm and 360 nm. So workable wavelengths selected were 238 nm and 281 nm for a Method I and 281 nm and 360 nm for Method II. Estimation of Amlodipine besylate was done directly from its absorbance at 238 nm and 360 nm for method I and II respectively. While estimation of Nebivolol hydrochloride was done by the equations derived. The method is validated statistically. The recovery studies confirmed the accuracy of the proposed methods.
7.  Ketan Shah, Desai TR, et el; Developed spectrophotometric methods for estimation of Nebivolol Hydrochloride and hydrochlorothiazide simultaneously, in bulk and tablet dosage form. The goal of the investigation was to develop new spectrophotometric methods viz. AUC method and first derivative spectroscopy method, for simultaneous determination of Nebivolol hydrochloride (NEB) and Hydrochlorothiazide (HCT) in bulk and in combined tablet dosage form, which were used for the validation of linearity, accuracy and precision. One of these methods involved for solving of simultaneous equations based on measurement of AUC at two wavelengths range 312-322 nm and 285-295 nm. Another method was first derivative spectroscopy, which was adapted to eliminate spectral interference. This method employs formation and solving of simultaneous equation using 292 nm (λ1) and 279 nm (λ2) as two analytical wavelengths. Both the drugs obey linearity with absorbance in the concentration ranges employed for these methods. The methods have been validated statistically and by recovery studies. These methods were found to be simple, sensitive, rapid, accurate, reproducible and economical.
8.  Walsangikar Sandeep, Ghate Snehal A et al. developed and validated spectrophotometric method for estimation of Nebivolol in tablet dosage forms and biological fluid. A simple, sensitive and accurate spectrophotometric method was developed in ultraviolet region for the estimation of Nebivolol (NEB) in pure drug, pharmaceutical formulation. Linear response obtained was in the concentration range of 5-45 µg/ml with correlation coefficient of 0.9995, 0.9989 in solvent and plasma respectively. Excellent recovery proved that the method was sufficiently accurate. There was no interference from any common pharmaceutical additives and diluents. Results of the analysis were validated by recovery studies according to ICH Q2(R1) guidelines and the same method is applied for estimation of NEB from plasma and these results were validated according to USFDA guidelines for bioanalytical method.
9.  R. K. Patel, J. B. Patel A et al. for the determination of Nebivolol HCl (NEB-H) and Hydrochlorothiazide (HCTZ) developed an accurate, precise and sensitive UV spectrophotometric method by in bulk as well as in the pharmaceutical formulation. Calibration curves were linear in range of 10-80 µg/mL (r2=0.999) and 2-16 µg/mL (r2=0.998) at λmax of 281 and 271nm for Nebivolol HCl and Hydrochlorothiazide respectively. The method was validated statistically.
ENCLOSURE-III
6.3 Objectives of the study
·  The main objective of the work is to develop a evaluation method for the estimation of Lorcaserine hydrochloride in tablet dosage form and in bulk drug by obsorving the λmax and estimated by spectrophotometrically.
7. MATERIALS AND METHODS:
Materials:
(1)  Lorcaserine hydrochloride tablets
(2)  Different solvents
(3)  Different equipments like: shimadzu U V 1700 spectrophotometer (shimadzu), High precision balance 1 mg sensitivity (model:PGB 200 WENSAR)
Methods:
·  The Spectrophotometric method for estimation of therapeutic active compound by observing the λ max of the sample and evaluate.
ENCLOSURE-IV
7.1. Source of Data
1) Review of literature from :
a. Journals : such as
- Indian journal of pharmaceutical sciences.
- International journal of comprehensive pharmacy.
- International journal of pharmaceutical research.
- European journal of pharmaceutical sciences.
- Indian journal of chemistry and technology.
- Asian journal of chemistry.
b. Internet browsing.
2) Library: M.M.U College of pharmacy., Ramanagara
3) Laboratory based studies.
ENCLOSURE-V
7.2. Method of Collection of Data
1.  Procurement of the drug sample and chemicals.
2.  Determine the solubility of Lorcaserine hydrochloride drugs in various solvents and buffers.
3.  Scanning the solution in UV-Visible region and selecting the solvents for various analytical studies.
4.  Preparation of standard calibration curve
5.  Validation of developed analytical method as per ICH guidelines.
ENCLOSURE-VI
7.3. Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please mention briefly.
-NO-
7.4. Has ethical clearance been obtained from your institution in case of 7.3?
-NOT APPLICABLE-
ENCLOSURE-VII
8. LIST OF REFERENCES
1.  M. Mathrusri Annapurna S,P,S , Bisht et el, “Spectrophotometric determination of bosentan and its application in pharmaceutical analysis ”pharmacieglobale(1)cp]2011, 2(01) issue No 0976-8157
2.  Hemanth kumar.A.K, .Sudha V, Swaminathan, “Comparison of HPLC and Spectrophotometric” (Indian journal of medicine) 2010, page no132:390:4
3.  Willard, Merritt, Dean, Settli, Text book of instrumental method of analysis, 6th edition, CBS publications, 1986, page no.66-90.
4.  Jack E Wallace “Determination of phenenyramidol in biological specimens by u.v spectroscopic method”, Indian journal of pharmaceutical sciences,Vol-58, issue 12 page no.1489-1492.
5.  Adhikari. L. A et al. they developed two simple and sensitive specrophotometric method in UV region and Visible region were developed for the estimation of Nitazoxanide in its pharmaceutical dosage forms.
6.  Pradeep mishra, Kamal shah A et al. developed simultaneous estimation of Nebivolol hydrochloride and Amlodipine besylate in tablet dosage form.
7.  Lopamudra Adhikari, Sanjiv sahu, Sarbeswar Jagdev, “Development and validation of Spectrophotometric and colorimetric method for the determination of Nitazoxanide in its bulk and pharmaceutical dosage form (tablets),International journal of chemTech Research, vol:3 no.1,pp 131-135 Jan-march 2011.
8.  Sandeep S. Sonawane, Atul a. Shirkhedkar, et al ,application of u.v spectrophotometry and reverse phase HPLC for simultaneous determination of atarvastatin calcium and Ezetimibe in pharmaceutical dosage forms”Eurasian journal of analytical chemistry, Vol:I 2006.
9.  Sethi P.D, Text book of quantitative analysis of drugs in pharmaceutical formulations, 3rd edition, page no. 127,383-386.
10.  Hamalata. M Nimje (1), Rajesh J Oswal”Application of UV spectroscopy for estimation & development Emitricibine in bulk & capsules.” Indian journal of pharmaceutical Research & development ; 2010 Article No 12.
11.  Ketan Shah, Desai TR, et el; Developed spectrophotometric methods for estimation of Nebivolol Hydrochloride and hydrochlorothiazide simultaneously, in bulk and tablet dosage form.
12.  Walsangikar Sandeep, Ghate Snehal A et al. developed and validated spectrophotometric method for estimation of Nebivolol in tablet dosage forms and biological fluid.
13.  R. K. Patel, J. B. Patel A et al. UV spectrophotometric method for the determination of Nebivolol HCl (NEB-H) and Hydrochlorothiazide (HCTZ) in bulk as well as in the pharmaceutical formulation.