Adaptation of Color Reactions for Spectrophotometric Determination of Mosapride Citrate in Formulations

 

Srinivasa Rao Narala¹* and K. Saraswathi²

¹Department of Chemistry, R.V.R. & J.C. College of Engineering, Guntur, A.P., India.

² Department of Chemistry, S.V. University, Tirupathi, A.P., India.

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

ABSTRACT:

Three new, simple and sensitive visible spectrophotometric methods (A, B and C) have been developed for the determination of Mosapride Citrate in bulk drug and pharmaceutical formulations. Method A is based on the condensation of Mosapride Citrate with salicylaldehyde to form schiff’s base, which was a yellow colored chromogen exhibiting λ_max at 410 nm. Method B is based on the formation of pink colored chromogen obtained when Mosapride Citrate was diazotized with nitrous acid followed by coupling with α-naphthyl amine, exhibiting  λ_max at 520 nm. Method C is based on the oxidation of Mosapride Citrate with Fe (III) and the estimation of Fe (II) produced after chelation with potassium ferricyanide, which was a bluish green colored chromogen, exhibiting λ_max at 770 nm. The Beer’s law was obeyed in the concentration range of 4-20, 10-40 and 4-24 µg/ml for methods A, B and C respectively. The results of the proposed methods have been validated statistically and by recovery methods.

 

 

 

INTRODUCTION:

Mosapride Citrate is chemically (±) - 4- amino - 5 - chloro- 2 – ethoxy – N - (4 - ( 4 - fluero benzyl ) – 2 – morpholinyl) methyl) - benzamide, 2 – hydroxyl - 1,2,3-propane tricarboxylate. It is a potent gastroprokinetic drug and is used in gastro intestinal symptoms associated with chronic gastritis. It behaves as a selective 5- HT₄  - receptor agonist and enhances only upper gastrokinetic motor activity. The literature survey reveals that few analytical methods for this drug are reported, which include chromatographic^1-2 and spectrophotometric^3-10 methods. In the present study three simple and accurate spectrophotometric methods have been developed for the estimation of Mosapride Citrate in bulk and pharmaceutical formulations.

 

EXPERIMENTAL:

Apparatus:

A Tech-comp model UV-2301 UV-Visible spectrophotometer with 1 cm matched quartz cells were used for all spectral measurements. Pure drug was obtained from local pharmaceutical laboratory, Hyderabad and its commercial formulations were procured from the market.

 

Reagents :

All the chemicals used were of analytical grade. Aqueous solutions of ferric chloride (0.5% w/v), potassium ferricyanide (0.2% w/v), sodium nitrite (0.5% w/v), ammonium sulphamate (0.5% w/v), HCl (1N, 5N) and alcoholic solutions of salicylaldehyde (4.0% v/v),   α-naphthyl amine (0.1% w/v) were prepared for these investigations.

 

Preparation of Standard solution :

Accurately weighed 100 mg of Mosapride Citrate was dissolved in 100 ml of methanol in a volumetric flask to obtain a concentration of 1mg /ml. From this suitable dilutions were made to obtain the working standard concentrations of 200 µg/ml, 500 µg/ml and 200 µg/ml for methods A, B and C respectively.

 

Preparation of sample solution:

Accurately weighed tablet powder equivalent to 100 mg of drug was transferred in to a 100 ml volumetric flask containing 50 ml of methanol, sonicated for 10 min. and diluted to 100 ml with methanol. The resulting solution was filtered through a whatmann filter paper. This solution was further diluted with methanol to obtain the working standard concentrations of 200 µg/ml, 500 µg/ml and 200 µg/ml for methods A, B and C respectively.

 

 

Table-1 Optical characteristics of the proposed methods

Parameter	Method A	Method B	Method C
λ max	410	520	770
Beer’law limits (µg/ml)	4-20	10-40	4-24
Molar absorptivity  ( l mol-1 cm-1)	2.4038X103	1.3852X103	3.1069X103
Sandell’sensitivity  ( µg cm-2)	0.2554	0.4432	0.1976
Regression equation  ( Y= mX+b )
Slope ( m )	0.0269	0.0214	0.0303
Intercept ( b )	-0.0124	0.0390	0.0039
Correlation coefficient	0.9999	0.9999	0.9995
R.S.D.(%)*	0.8172	0.9278	0.4392
% Range of error  (confidence limits)
0.05 level	± 1.0146	± 1.1518	± 0.5459
0.01 level	± 1.6827	± 1.9103	± 0.9053

* Mean of five determinations

 

Table-2  Amount of Mosapride Citrate found in  formulations by proposed methods

Fomulation	Labeled amount mg/tablet	Amount found *			%  Recovery **
		Method A	Method B	Method C	Method A	Method B	Method C
Tablet-1	5.0	4.97± 0.019	4.97 ± 0.028	4.96 ± 0.042	99.87 ± 0.101	99.93± 0.023	99.89 ± 0.031
Tablet-2	5.0	4.99± 0.029	4.98± 0.022	4.98 ± 0.018	99.78± 0.051	99.95± 0.061	99.75 ± 0.084

* Mean of five determinations

** Mean of three determinations

 

Assay Procedure:

Method A

Aliquots of standard drug solution ranging from 0.5 to 5.0 ml (200 µg/ml) were transferred to a series of heating tubes. To each tube 2.0 ml of salicylaldehyde and 0.5 ml of concentrated hydrochloric acid were added and heated for 15 min. at 60-70⁰C on a water bath and then cooled to room temperature. The contents of the tubes were transferred to a series of 25 ml standard flasks, and then diluted to the mark with methanol. The absorbance of yellow colored chromogen was measured at 410 nm against a reagent blank. The amount of drug in the sample was computed from its calibration curve.

 

Method B

Aliquots of standard drug solution ranging from 0.5 to 5.0 ml (500 µg/ml) were transferred to a series of 25 ml volumetric flasks. To each flask 1.0 ml of 5N HCl, 1.0 ml of sodium nitrite were added and kept for five min. at 0-5ºC. To which 1.0 ml of ammonium sulphamate, 1.0 ml of alcoholic α- naphthyl amine were added and kept for five min. Finally the volume is made up to the mark with distilled water. The absorbance of pink colored chromogen was measured at 520 nm against a reagent blank. The amount of drug in the sample was computed from its calibration curve.

 

Method C

Aliquots of standard drug solution ranging from 0.5 to 5.0 ml (200 µg/ml) were transferred to a series of 25 ml volumetric flasks. To each flask 1.0 ml of ferric chloride and 2.0 ml of Potassium ferricyanide were added and kept for 10 min. To this 1.0 ml of 1N HCl is added and the volume is made up to the mark with distilled water. The absorbance of bluish green colored chromogen was measured at 770 nm against a reagent blank. The amount of drug in the sample was computed from its calibration curve.

 

RESULTS AND DISCUSSION:

The optical characteristics such as Beer’s law limits, Molar absorptivity, Sandell’s sensitivity and relative standard deviation were calculated and the results are summarized in Table 1. Regression characteristics like slope, intercept and correlation coefficient were calculated and are presented in Table 1.

 

Commercial formulations of Mosapride Citrate were successfully analyzed by the proposed methods and the values are presented in Table 2. To evaluate validity and reproducibility of the methods recovery experiments were conducted and the results are summarized in Table 2.

 

CONCLUSION:

The proposed visible spectrophotometric methods for the estimation of Mosapride Citrate are simple, sensitive, accurate and can be used for the routine quality control of the drug in bulk as well as in pharmaceutical formulations.

 

ACKNOWLEDGEMENTS:

The authors express their gratitude to the Management R.V.R. & J.C. College of Engineering, Guntur for providing their continuous support throughout the work.

 

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Received on 03.03.2011        Modified on 17.03.2011

Accepted on 22.03.2011        © AJRC All right reserved