Simultaneous Estimation of Rabeprazole Sodium and Itopride Hydrochloride in Capsule Dosage Form by UV Spectrophotometry

 

Shaik Harun Rasheed1*, M. Arief1, P. Sandhya Vani1, Silpa Rani Gajavalli1, G. Venkateswarlu1, K. Shahul Hussain2, N. Vinay Kumar3 and Y. Krishna Reddy4

1 BA&KR College of Pharmacy, Doddavarapadu, Ongole, Andhra Pradesh, INDIA.              2Vagdevi College of Pharmacy, Nellore, Andhra Pradesh, INDIA.   3MRR College of Pharmacy, Nandigama, Andhra Pradesh, INDIA             4Sri Vani College of Pharmacy, Vijayawada, Andhra Pradesh, INDIA

*Corresponding Author E-mail: shaikharunrasheed@gmail.com

 

ABSTRACT:

The simple, accurate and precise methods for simultaneous estimation of Rabeprazole sodium and Itopride hydrochloride in capsule dosage form by Spectrophotometric method, the absorbance values at 284nm and 258nm for Rabeprazole sodium and Itopride hydrochloride. Beer-Lambert’s law over the concentration rang for Rabeprazole sodium was 1-5ug/ml and Itopride hydrochloride 7.5-37.5ug/ml, with r values between 0.9994-0.9998.The percentage recovery value was found to be 100%, it indicates there is no interferences of additives with Rabeprazole and Itopride present in capsule dosage form. The method has been validated as per ICH guidelines and %RSD value NLT 2(<2%) was found. The proposed method was successfully applied for estimation of Rabeprazole and Itopride in combined capsules dosages formulation.

 

KEYWORDS: Uv- Spectrophotometry, Rabeprazole sodium, Itopride hydrochloride 

 


 

INTRODUCTION:

Rabeprazole sodium1 is chemically (RP) 2-[[[4-(3-methoxypropoxy)-3-methyl-2- pyridil] - methyl] sulfinyl]-1H- benzimidazole Fig-1. It act orally by suppresses gastric acid secretion by inhibiting the  parietal cell H+/K+ ATP pump and used in Short-term treatment in healing and symptomatic  relief of duodenal ulcers and erosive or ulcerative gastro esophageal reflux disease (GERD); long- term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome and in combination with amoxicillin and clarithromycin to eradicate Helicobacter pylori.

 

Itopride hydrochloride (IH) is chemically N-[[4-(2-dimethylaminoethoxy) phenyl] methyl] -3, 4- dimethoxy-benzamide hydrochloride2 (Fig-2) used as a prokinetic agent. It act orally by increase the acetylcholine concentration by inhibiting dopamine D2 receptors and acetylcholine esterase higher acetyl choline concentration increases the GI peristalsis increase the lower esophageal sphincter pressure stimulate the gastric motility accelerate the gastric empting and improve the gastro duodenal co-ordination.

 

Literature survey reveals that various analytical methods 3-10 have been reported for rabeprazole and Itopride hydrochloride in single dosage forms. The present paper aims to report a simple U.V method for estimation of rabeprazole and Itopride hydrochloride in their combined dosage form.

 

Your browser may not support display of this image.Fig: 1 Structure of Rabeprazole

 

Your browser may not support display of this image.Fig: 2 Structure of Itopride Hydrochloride

 

Thousands of UV-Visible methods have been designed for the determination of single components in a sample. However, one of the advantages of Spectrophotometry over visual colorimetry is the ability to handle analysis of mixtures of absorbing species.

 

MATERIALS AND METHODS:

A Shimadzu UV/Visible double beam spectrophotometer (Model: UV-1700) with corrected wavelength accuracy of +/- 0.3nm and 1cm UV matched Quartz cells were used.

 

Chemicals and reagents:

Max Labs Ltd., India generously gifted pure IH and RP. Commercial tablets (Rabium plus Intas Pharma) containing RP (20 mg) IH (150 mg) were used for the study. Water, methanol used were of analytical grade (E.Merk, Mumbai, India). All the other chemicals used were of Analytical grade (E. Merk, India).

 

C) Preparation of Stock solution:

Accurately weighed 10 mg of Itopride pure drug was added in a 10 ml clean, calibrated volumetric flask and dissolved in 3ml methanol, then made up to 10 ml with 7 ml water to set a stock solution (1000µg/ml).  From the stock solution 1ml is pipetted out and made up 10 ml with methanol. The resulting solution was scanned in UV region for its absorbance maxima and was found to be 258nm. The absorption curve for Itopride was shown in figure 03.

 

Fig.3 UV Spectrum of Itopride 

 

Accurately weighed 10 mg of Rabeprazole pure drug was added in a 10 ml clean, calibrated volumetric flask and dissolved in 3ml methanol, then made up to 10 ml with 7 ml water to set a stock solution (1000µg/ml).  From the stock solution 1ml is pipetted out and made up 10 ml with methanol. From the above solution 0.1-0.5ml was pipetted out and made up to 10 ml with solvent to give different solutions with concentrations of 1-5 µg/ml respectively. The resulting solution was scanned in UV region for its absorbance maxima and was found to be 284nm. The absorption curve for Rabeprazole was shown in figure 04.

 

Your browser may not support display of this image.Fig.4 UV Spectrum of Rabeprazole 

 

d) Estimation of Itopride and Rabeprazole from formulation:

Twenty capsules each containing 150 mg of Itopride and 20 mg Rabeprazole were weighed and finely powdered in a mortar. From the powdered capsules, a quantity of powder equivalent to 10 mg was weighed accurately and treated with 10 ml of methanol and made up to 100 ml with water (100µg/ml). The solution is then filtered through Whatmann filter to get a clear solution. From this, 0.3 ml of solution was drawn and makes up to 10 ml with water. The resulting solution was scanned in UV region. The overlay spectrum for both the drugs was shown in figure 05.

 

Fig.5 Over Lay UV Spectrum of Rabeprazole and Itopride

 


Table: 1     Summary of validation parameter:

S. NO.

Parameter

Rabeprazole

Itopride

1

Linearity range      ( ug/ml)

1-5ug/ml

7.5-37.5 ug/ml

2

correlation coefficient (r)

0.9994 (284.5 nm)

0.9998 (258.5 nm)

0.9994 (284.5 nm)

0.9997 (258.5 nm)

3

Intraday  Precision  (%RSD)

Interday Precision  (%RSD)

1.7-0.59

1.88-1.42

0.83-0.308

0.83-1.12

4

%Recovery

98.074

98.85

 

Table 2. Analysis of commercial formulation:

Formulation

DRUG

Label claim(mg)

Estimated Amount (mg/tab)

%label claim

Standard deviation*

Formulation

(RABLET IT)

Rabeprazole

20

19.73

98.65

0.059

Itopride

150

150.6

100.41

0.136

Formulation

(VELOZ IT)

Rabeprazole

20

19.84

99.2

0.064

Itopride

150

150.79

100.5

0.105

* mean of six determinations.

 

Table 3.  Recovery studies (Accuracy)

Drug

Label claim

Amount added 100 %

% recovery

%RSD*

Rabeprazole

20mg

2

98.074

0.48

Itopride

150mg

10

98.85

0.55

* mean of six determinations.

 


The sample containing two absorbing species Itopride and Rabeprazole (X and Y)  each of which absorbs at the λ max of the other. So the absorbance of each drugs were measured at both wavelengths λ1 and λ2 respectively.

The both the drugs are determined by simultaneous method (Vierodt’s method). The absorptivity of Itopride (X) at λ1 (258.5) and λ2 (284.5) is ax1 ax2 respectively. The absorptivity of Rabeprazole(Y) at λ1 (258.5) and λ2 (284.5) is ay1 ay2 respectively.

Absorptivity =     absorbance / concentration

The absorbance of the sample (formulation) at λ1 (258.5) and λ2 (284.5) is A1 and A2 respectively. The total absorbance of the mixture is equal to the sum of individual absorbance of X and Y.

A1 = ax1bcx + ay1bcy

A2 = ax2bcx + ay2bcy

Cx – conc of Itopride Hydrochloride

Cy – conc of Rabeprazole sodium.

By using this formula the both drugsYour browser may not support display of this image. Itopride and Rabeprazole were estimated.

 

RESULTS AND DISCUSSION:

For UV Spectroscopic simultaneous equation method, various solvents were tried among the methanol was selected as solvent which gives good absorbance values with well resolved spectrum with good intensities, The preparation was found to be simple, accurate and precise methods for simultaneous estimation of Rabeprazole sodium and Itopride hydrochloride in capsule dosage form. Beer-Lambert’s law over the concentration range for Rabeprazole was 1 to 5ug/ml and Itopride 7.5 to 37.5ug/ml, with correlation coefficients (r)values for Rabeprazole sodium at 284.5 nm and 258.5 nm were 0.9994, 0.9998, respectively and the correlation coefficients for Itopride hydrochloride at 284.5 nm and 258.5 nm were 0.9994, 0.9997 respectively (Table No.1). The developed method was validated for accuracy and precision (Table 1). The percentage of recovery of Rabeprazole and Itopride was found to be 98.074%, 98.85%, 100% level it indicates there is no interferences of additives with Rabeprazole and Itopride present in capsule dosage form (Table No.1). The analysis of the commercial formulation was performed and the results were shown (Table No.2).The good recovery indicates the accuracy and reproducibility of the method (Table 3). The Interday, intraday, and repeatability studies were also performed (Table No.1). The method has been validated as per ICH guidelines and %RSD value NLT 2(<2%). Hence the developed method has been successfully employed to estimate the Rabeprazole and Itopride in combined dosage forms.

 

REFERENCES:

1.        David G Watson, Pharmaceutical Analysis, A textbook for Pharmacy students and Pharmaceutical chemists, 2: 286.

2.        Beckett AH and Stenlake JB. Practical Pharmaceutical Chemistry: CBS Publishers and Distributors. 1997; 157.

3.        Alfonso genera in Remington’s Pharmaceutical series, 18th – Edn. Mack publishing company, 1990; 648.

4.        Berezkin, VG and Horwoodv E. Chromatographic Adsorption Analysis. 1990

5.        Chung Chow Chan, Lee YC, Herman Lam, Xue – Ming Zhang. Analytical Method Validation and Instrument Performance Verification. 35-45.

6.        CDER Reviewer Guidance: Validation of Chromatographic Methods, Nov. 1994.

7.        Douglas A Skoog, Donald M West. and James Holler F., Fundamentals of Analytical Chemistry,1-3: 628-641.

8.        David C Lee and Michael Webb. Pharmaceutical Analysis: 1, 32, 44

9.        Gurdeep R Chatwal, Sham, K. and Anand. Instrumental methods of Chemical Analysis. 5, 561-567

10.     Galen WE. Instrumental Methods of Chemical Analysis. 5th Edn: Mc Graw-Hill International Editions, 1.

 

 

 

 

Received on 03.10.2010          Modified on 10.11.2010

Accepted on 28.11.2010         © RJPT All right reserved

Research J. Pharm. and Tech. 4(4): April 2011; Page 558-560