“DEVELOPMENT OF SPECTROPHOTOMETRIC METHODS FOR THE ESTIMATION OF SOME WATER INSOLUBLE CALCIUM CHANNEL BLOCKERS USING HYDROTROPIC SOLUBILIZATION TECHNIQUE”

DISSERTATION PROTOCOL

Submitted to the

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

BY

SURESH CHOUDHARY

M.Pharm Part-1

DEPARTMAENT OF PHARMACEUTICAL CHEMISTRY

UNDER THE GUIDANCE OF

Mr.M.GURUMURTHY M.Pharm

ASSISTANT PROFESSOR

Department of pharmaceutical chemistry

Dr H.L.T College of pharmacy

Kengal, chennapatna -571502

2008

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the Candidate and
Address( in Block Letters) / SURESH CHOuDHARY
M. Pharm, Part-I
DEPARTMENT OF PHARMACEUTICAL CHEMISTRY
Dr. H. L. T. COLLEGE OF PHARMACY
KENGAL, CHANNAPATNA-571502
BANGALORE (RURAL), KARNATAKA.
2. / Name of the Institution / Dr. H.L.T. College of Pharmacy
Kengal, Channapattana-571 502
3. / Course of Study and Subject / Master of Pharmacy
Pharmaceutical Chemistry
4. / Date of Admission to the Course / 06-06-2008
5. / Title of the Topic / “DEVELOPMENT OF SPECTROPHOTOMETRIC METHODS FOR THE ESTIMATION OF SOME WATER INSOLUBLE CALCIUM CHANNEL BLOCKERS USING HYDROTROPIC SOLUBILIZATION TECHNIQUE”

6) BRIEF RESUME OF THE INTENDED WORK:

6.1) NEED FOR THE STUDY :

Increasing the aqueous solubility of insoluble and slightly soluble drugs is of major importance . various techniques have been employed to enhance the aqueous solubility

of poorly water soluble drugs . hydrotropic solubilization is one of them . the term hydrotropy has been used to designate the increase in solubility in water of various substance due to presence of large amount of additives1. sodium acetate ,sodium salicyclate , sodium benzoate , urea , nicotinamide , sodium citrate are the most common examples of hydrotropic agents2,3 . maheswari et al , have developed various analytical techniques employing hydrotropic solubilization phenomenon to analyze poorly water soluble drugs like hydrochlorothiazide4 , aceclofenac5 and ketoprofen6.

Various organic solvents such as methanol , chloroform , dimethyl formamide and acetonitrile have been employed for solubilization of poorly water soluble drugs to carry out spectroscopic analysis . draw back of these organic solvents include high cost , volatality , pollution and toxicity such as nephrotoxicity or teratogenecity , organic solvents are harmful if swallowed ,inhaled or absorbed through skin . also as per I.C.H guide line Q3 CR3 (impurities guide line for residual solvents ) these solvent comes under category of Class 2 solvent i.e solvents which are in limited use. So there is an urgent need to replace organic solvent by safe eco friendly , cost effective solvent for spectrophotometric analysis . therefore it was thought worth while to employ hydrotropic technique to carry out spectrophotometeric estimation of some water insoluble calcium channel blockers like amlodepine , felodipine , nemodipine , nifedipine , nitrendipine etc in bulk and in dosage forms . calcium channel blockers mainly used in antianginal , antihypertensive and antiarrhythmic activity. These drugs are not official in any therapeutic compendia. Hence no official method available for these drugs.

A literature survey reveal calcium channel blocker are estimated by HPLC , HPTLC , UV and colorimetric methods using various organic solvents .to our knowledge there is no spectrophotometeric method except nifedipine7 by hydrotropic technique has been developed. through this work an attempt is being made to develop and validate simple, Economical and sensitive method employing hydrotropic solubilization technique for quantitative monitering of Some water insoluble calcium channel blockers in bulk and in dosage forms.

6.2.) REVIEW OF LITERATURE

The review of various published work related to subject revealed the following

1. Neuberg c et al Bio chemical ,z.76:107.1916

2.jain NK.Patel VV . Hydrotropic solubilization estern pharmacist 1986; 29:51-3

3.maheshwari r.k,.chaturvedi s.c ,jain n.k. application of hydrotropy in spectrophotometric determination of pharmaceutical dosage froms Indian drugs 2005:42;76-3

4. maheshwari r.k,.chaturvedi s.c ,jain n.k. Application of hydrotropic solubilization phenomenon in spectrophotometeric analysis of hydrochlorothiazide tablets Indian drugs 2005; 24:541-4

5. maheshwari r.k,.chaturvedi s.c ,jain n.k. , titrimetric analysis of aceclofenac in tablet using hydrotropic solubilization technique Indian drugs 2006 ;43:516-8

6. maheshwari r.k,.chaturvedi s.c ,jain n.k. Application of hydrotropic solubilization

In the analysis of bulk sample of ketorprofen and salicyclic and asian j chem. 2006,18:3 93-6

7. jain n.k agrawal R.K singhai AK , hydrotropic solubilization of nifedipine pharmzie 1990;45:221-5

6.3.) MAIN OBJECTIVES OF THE STUDY :

There is a broad scope for hydrotropic agent in quantitative estimation of poorly water soluble drugs

The present work is an attempt

1. to study and develop spectroscopic methods employing hydrotropic solubilization phenomenon for quantitative estimation of some water insoluble calcium channel blocker for quantitative estimation and validation of the method according to ICH guide lines

2. to develop an accurate selective precise and specific method for the estimation of these drugs in pharmaceutical dosage forms

3. to develop the method having reproducible results.

4. to develop a method having that appears to be suitable for quality control in pharmaceutical industry due to its sensitivity . simplicity selectivity and lack of excipients interferences.

5. an over all conclusion will be drawn regarding the result obtain during the course

of any research with publication in national and international journals respectively.

7. MATERIALS AND METHODS:

7.1) SOURCE OF DATA

The preliminary data required for the experimental study is obtained from .

  1. CD-Rom search available at national center for scientific information (NCSI), Indian institute of Sciences, Bangalore.
  2. Journals
  3. Analytical chemistry Books
  4. Library
  5. Relevant Books
  6. Internet Sources
  7. Scientific abstracts.

7.2) METHODS OF COLLECTION OF DATA:

The preliminary data required for the experimental study is obtained from –

  1. CD-Rom search available at National Center of Scientific Information (NCSI), Indian institute of Sciences, Bangalore, Dr. H.L.T. College of Pharmacy Library, Scientific abstracts, Journals, Internet sources and Relevant Books
  2. The data will be collected by Laboratory investigation and Recording the data.

7.3) Does the Study require any investigation to be conducted on

Patients/Humans/ Animals ? If so, please describe briefly.

NO.

7.4) Has ethical Clearance been obtained from your institution in case of 7.3

NOT APPLICABLE

8. LIST OF REFERENCES:

  1. Neuberg c et al Bio chemical ,z.76:107.1916
  2. jain NK.Patel VV . Hydrotropic solubilization estern pharmacist 1986; 29:51-3
  3. maheshwari r.k,.chaturvedi s.c ,jain n.k. application of hydrotropy in spectrophotometric

determination of pharmaceutical dosage froms Indian drug 2005:42;76-3

  1. maheshwari r.k,.chaturvedi s.c ,jain n.k. Application of hydrotropic solubilization phenomenon in spectrophotometeric analysis of hydrochlorothiazide tablets Indian drugs 2005; 24:541-4
  2. maheshwari r.k,.chaturvedi s.c ,jain n.k. , titrimetric analysis of aceclofenac in tablet using hydrotropic solubilization technique Indian drugs 2006 ;43:516-8
  3. maheshwari r.k,.chaturvedi s.c ,jain n.k. Application of hydrotropic solubilization In the analysis of bulk sample of ketorprofen and salicyclic and asian j chem. 2006,18:3 93-6
  4. jain n.k agrawal R.K singhai AK , hydrotropic solubilization of nifedipine pharmzie 1990;45:221-5
  5. Dake A.S; Kasture V.S , and Syed M.R; Spectrophotometeric estimation of amlodipine besylate and enalopril maleate in tablet; Indian drug ,2002, 3g(1),14-17
  6. jain H.K and Agrawal R.K Spectrophotometeric estimation of amlodipine besylate and lisinorpril in tablet, Indian drugs ,2002,37(4),196-199
  7. Mashru R.C, et al ; development of method of simultaneous estimation of amlodipine of simultaneous estimation of amlodipine besytale and lisinopril in their in combined dosage form; east pharm , 2002 43(513),111-112
  8. Ramteke M.K and kasture A.P ; simultaneous estimation of atenolal and nefedipine in combined scientific abstract , 2003/6-25.20 Meyya S.N; Nathan G.V.S; Ramasarma and suresh B; Simultaneous spectrometric estimation of benazepril and amlodipine besylate in their dosage form ; the Indian pharmacist 2003,2(7),100-101
  9. panderi i.e ; spectrophotometeric determination of benazepril and hydr(2ochlorthiazide in tablet 2nd order derivative.Spectrophotometry ; J. pharm. .Biomed Anal., 1999,21(2),257-265
  10. Topale P.R , Gaikwad N.S and Tajane M.R; simultaneous u.v spectrophotometeric estimation of losarton potassium and amlodipine in tablet; Indian drugs 2003, 40(2),119-121
  11. Argekar A.P and Pawar S.C; simultaneous determination of amilodipine and atenalal in tablet by HPLC; J.pharm, Biomed Anal,2002,21(6)1132-1142
  12. Rao J.R; Kadam S.S and Mahadik K.P; HPLC determination of amlodipine and benazepril Hcl in talblet; Indian drugs ,2002 , 3g(7),378-381
  13. Gowri N; vidhyalingam V and santha A ;simulataneous estimation of amlodipine and benazepril from tablet by RP-HPLC Indian drug ,2001.38,332-335.
  14. Zarapkar S.S and kanyawar N.S ; Simulataneou estimation of amlodipine and losarton potassium in pharmaceutical dosage from by RP-HPLC; Indian drugs 2002,3g(6),341-343
  15. Gawri N; vaidhyalingam V and santha A ; HPLC method for the simultaneous estimation of amlodipine besyalte and benazepril Hcl tablets ; Indian drugs ,2003,40(11),645-648.

9. / Signature of the Candidate
10. / Remarks of the Guide / Topic selected for Dissertation work is satisfactory. This can be carried out in our Laboratory.
11. / Name and Designation of
( In Block Letters)
11.1Guide
11.2Signature / Mr.M. GURUMURTHY. M.Pharm.
ASSISTANT PROFESSOR,
DEPARTMENT OF PHARMACEUTICAL CHEMISTRY
Dr. H.L.T. COLLEGE OF PHARMACY,
KENGAL, CHANNAPATNA- 571 502
BANGALORE (RURAL), KARNATAKA..
11.3Co-Guide (If any)
11.4Signature
11.5Head of the
Department
11.6Signature / Mr. M. GURUMURTHY, M. Pharm
ASSISTANT PROFESSOR
DEPT.OF PHARMACEUTICAL CHEMISTRY
Dr. H.L.T. COLLEGE OF PHARMACY,
KENGAL, CHANNAPATTANA-571 502,
Dist: Ramanagar.
12. / 12.1 Remarks of the
Chairman and
Principal
12.2 Signature / Topic selected for Dissertation work is satisfactory. This can be carried out in our Laboratory.

From

SURESH CHOUDHARY, M.Pharm Part-1

DEPARTMENT OF PHARMACEUTICAL CHEMISTRY

Dr. H.L.T. COLLEGE OF PHARMACY

KENGAL, CHANNAPATNA,

BANGALORE (RURAL)-571 502.

To

THE REGISTRAR (EVALUATION),

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA BANGALORE

4TH “T” BLOCK, JAYANAGAR,

BANGALORE-560 041.

(THROUGH PROPER CHANNEL)

SUB : SUBMISSION OF SYNOPSIS OF DISSERTATION.

RESPECTED SIR,

HEREWITH, I AM SUBMITTING SYNOPSIS OF DISSERTATION WORK “DEVELOPMENT OF SPECTROPHOTOMETRIC ESTIMATION OF SOME WATER INSOLUBLE CALCIUM CHANNEL BLOCKERS USING HYDROTROPIC SOLUBILIZATION TECHNIQUE” FOR REGISTRATION IN M.PHARM. (PHARMACEUTICAL CHEMISTRY) OF RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA BANGALORE.

KINDLY ACCEPT THE SAME AND OBLIGE.

THANKING YOU,

YOUR’S FAITHFULLY,

Place : Channapatna. (SURESH CHOUDHARY)

Date :

GUIDE :

MR. M. GURUMURTHY

ASSISTANT PROFEESSOR & HEAD OF PRINCIPAL

DEPT. OF PHARMACEUTICAL CHEMISTRY DR. H.L.T. COLLEGE OF PHARMACY

DR. H.L.T. COLLEGE OF PHARMACY KENGAL , CHANNAPATNA.

CHANNAPATNA. BANGALORE (R), KARNATAKA