Simultaneous Estimation of Omeprazole and Cisapride in Pharmaceutical Dosage Form

Vijaya P. Godse*, Mane Shrinivas R, AV Bhosale and AV Kasture

Seth Govind Raghunath Sable College of Pharmacy,Saswad, Tal - Purandar, Dist.Pune.412301

*Corresponding Author E-mail: godse_vijaya@rediffmail.com

 

ABSTRACT

A simple, rapid, reproducible and economical procedure for routine simultaneous analysis of Omeprazole and Cisapride in oral dosage form has been developed using multicomponent mode of analysis. The method is based on the native Ultraviolet absorbance maximas of the two drugs in methanol. The interference among the components of the formulations was reduced by employing five mixed standards and four sampling wavelengths of 214.5nm, 221.5nm, 230nm and 240nm.The method has been validated statistically. The recovery was between 99 to 101%.

 

KEYWORDS: Omeprazole, Cisapride, multicomponent mode

 


INTRODUCTION:

Omeprazole (OMP) is a proton pump inhibitor which is used as Antiulcer and Antisecretory agent. It is chemically 5- methoxy-2[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole. It is official in I.P., B.P. and U.S.P. Cisapride (CSP) is a Prokinetic drug which increases the GI motility. It is chemically Cis-4-Amino-5-Chloro-N-[1-[3-(4-fluorophenoxy)propyl]-3-methoxy-4-piperidinyl]-2-methoxy benzamide. It is official in B.P. and Martindale. Literature survey reveals that several methods such as UV spectrophotometric1-2 and HPLC3-5 and HPTLC6 have been reported for estimation of omeprazole in pharmaceutical formulation and certain spectrophotometric7-8 and HPLC9 have been reported for estimation of cisapride. We have developed HPTLC10 method for simultaneous estimation of omeprazole and cisapride but no UV multicomponent method found to be reported for simultaneous estimation of the omeprazole and cisapride in combined dosage form. A successful attempt has been made to estimate the two drugs simultaneously by multicomponent mode of analysis.

 

EXPERIMENTAL:

INSTRUMENTAL

(1)    Shimadzu UV/Visible spectrophotometer (Model: UV 1601 A) with :

a) Spectral bandwidth (Resolution): 2 nm.

b) Wavelength accuracy: +/- 0.5 nm (with automatic wavelength correction).

(2)    Matched quartz cells (10mm).

(3)    A Shimadzu electronic analytical balance (AX-2000)

(4)    Ultrasonic cleaning bath (UCB-30)

 

Solvent: Methanol (A.R.Grade)

 

PROCEDURE:

Standard stock solutions

Standard stock solutions of strength 200 mcg/ml of Omeprazole and 100 mcg/ml of Cisapride were made in methanol.

 

Mixed Standards

The mixed standards having the composition shown in Table I was made in methanol. The five mixed standard solutions were scanned over range of 400-200nm in multicomponent mode of analysis using four sample points of 214.5nm, 221.5nm, 230nm and 240nm obtained from overlain spectra of Omeprazole (10mcg/ml) and Cisapride (10mcg/ml) .The overlain spectra of Omeprazole and Cisapride and five mixed standards are shown in Fig.1 and 2 respectively.

 

The spectral data from these scans of mixed standards was used to determine the concentrations of two drugs in capsule sample solutions.

 

Preparation and Analysis of Capsule sample Solutions

Twenty capsules were weighed, contents emptied and finely mixed. Accurately weighed capsules powder equivalent to 50 mg Omeprazole were added in 40 ml of methanol, shaken for 10 minutes and then filtered through Whatman filter paper (no.41) in 50 ml volumetric flask. The residue was washed with small aliquots of methanol and washing were collected in same volumetric flask and volume was adjusted to 50 ml mark. From the above solution, final dilutions were made with methanol to get the final concentration within the concentration range of mixed standards. This sample solution was scanned over the range of 200-250 nm wavelengths and the concentration of each drug was determined by analysis of spectral data of the sample solutions with reference to the mixed standards. The results are summarized in Table II.

Table 1: Concentrations of Omeprazole (OMP) and Cisapride (CSP) in five mixed standards

Concentration (mcg/ml)

Std 1

Std 2

Std 3

Std 4

Std 5

Omeprazole

2

4

6

8

10

Cisapride

1

2

3

4

5

 

Fig.1.Overlain Spectra of Omeprazole and Cisapride

 

Fig.2. Overlain Spectra of Five Mixed Standards

 


 

Table 2: Analysis of Marketed Formulation

Sample

Label Claim (mg/capsule)

% Label Claim *

Standard Deviation

Standard Error

Coeff. Of Variation

ZOSECPRO

OMP-20

98.94

0.3114

0.1392

0.3147

CSP-10

101.07

0.2215

0.0990

0.2191

*Mean of Five Estimations

 

Table 3: Recovery Studies Data

Sr. No.

Quantity of Drug Added(mg)

Quantity Found(mg)

% Recovery

 

OMP

CSP

OMP

CSP

OMP

CSP

1.

24.101

13.01

23.98

13.10

99.49

100.69

2

25.432

12.25

25.24

12.31

99.24

100.48

3

26.53

13.28

26.41

13.25

99.54

99.77

4

25.01

12.53

24.90

12.41

99.56

99.04

 

Table 4: Statistical Validation of Recovery Results

Drugs

Mean

Standard Deviation

Standard Error

Coeff. Of Variation

OMP

99.99

0.3651

0.1825

0.3651

CSP

99.95

0.4849

0.2424

0.4851

 

 


Recovery studies

The recovery studies were carried out by adding known amount of standard solution of omeprazole and cisapride to pre-analyzed capsule solutions. The results of recovery studies were found to be satisfactory and the results are presented in Table III and IV.

 

CONCLUSION:

The proposed method was found to be simple, rapid and economical for routine simultaneous determination of the two drugs without prior separation. After several trials the use of five mixed standards and four sampling wavelengths has been found to reduce interference among the two components. The values of standard deviation and coefficient of variation were satisfactorily low and recovery studies indicate the reproducibility and accuracy of the method.

 

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Received on 25.03.2009 Modified on 21.06.2009

Accepted on 12.07.2009 RJPT All right reserved

Research J. Pharm. and Tech.2 (3): July-Sept. 2009,;Page 605-606