Spectrophotometric method of Choline Bitartrate in bulk and its tablet formulation

G. Krishnamoorthy*, C. Diana Priyadarshini, R. Senthamarai

Department of Pharmaceutical Analysis, Periyar College of Pharmaceutical Sciences, Tiruchirappalli – 620 021.

*Corresponding Author E-mail: vkm292011@hotmail.com

ABSTRACT:

A Simple, precise, rapid and accurate UV spectrophotometric method was developed for the estimation of Choline Bitartrate in bulk and its tablet formulation. UV scan of Choline Bitartrate showed λmax (absorbance) value at 208 nm in the concentration range of 10 µg/ml. This method is based on the measurement of light absorption in the UV region using water as solvent. Beer’s Law plot was constructed by measuring the absorbance at 208 nm using various concentration of solution 5-35 µg/ml and show linearity and limit of detection. A simple and convenient method is applied to the determination of amount of choline bitartrate present in tablet formulation with high percentage of recovery, good accuracy and precision. The results are found satisfactory and reproducible. The proposed method was successfully extended to pharmaceutical preparation tablet.

KEYWORDS: Choline Bitartrate, UV spectrophotometry absorption maxima, Pharmaceutical formulation, Beer’s range, Recovery studies.

INTRODUCTION:

Choline Bitartrate is involved in variety of intricate biochemical reactions involving multiple systems of the body, including the brain, musclas and internal organs. Specifically, we need choline in order to form healthy cell membranes, breakdown of cholesterol, and aid in the function of neurotransmitters in the brain^1-5. Chemically it is (2- Hydroxyethyl) trimethylammonium – L – (+) – tartrate salt (Fig.1). Its molecular weight is 253.25 and molecular formula is C₉H₁₉NO₇. Literature survey reveals no ultra violet spectrophotometry method developed for the estimation of choline Bitartrate in bulk and its tablet formulation. The aim of the study was to develop a simple, precise and accurate spectrophotometric method for the estimation of choline bitartrate in bulk and its tablet formulation. Several analytical techniques like HPLC, Non-aqueous titration have been reported for routine analysis. So the authors have made some attempts in developing UV spectrophotometric method.

CHEMICAL STRUCTURE²

Fig.1 Chemical structure of choline bitartrate

MATERIALS AND METHODS:

Apparatus and Chemicals:

A Shimadzu UV–Visible spectrophotometer 1601 with 1cm matched quartz cells was used for all spectral measurements. All chemicals were of analytical reagent grade and solutions were prepared with purified water pharmaceutical grade of choline Bitartrate was gifted by Goodman pharmaceuticals, Puducherry, India.

Absorption Spectra of Choline Bitartrate in Water

About 100mg of choline bitrartrate in pure was dissolved in 100 ml of water to get 1 mg/ml stock solution. It was diluted with same solvent to get 100 µg/ml. and it was further diluted with same solvent to get 10 µg/ml. The prepared stock solution was stored at dark place protected from light. From this stock solution, a series of standards were freshly prepared during the analysis day³.

ASSAY OF CHOLINE BITATRATE IN TABLET FORMULATION

Working Standard Solution:

A standard stock solution was prepared by dissolving 100 mg of Choline Bitartrate in 100 ml water, and further diluted with same solvent to get 100 µg/ml.

Preparation of Sample Solution:

Ten tablets were weighed, and then powdered sample of the powdered tablets, equivalent to 75mg of the active ingredient was weighed and dissolve in 100ml of purified water and further diluted with water to get 75 µg/ml. This experiments was repeated 5 times for tablet formulation to find the drug content in each tablet. Readings were taken and shown in Table no.1.

Recovery Studies:

To study the accuracy and reproducibility of the UV method, recovery experiments were carried out. The recovery experiments were performed for tablet formulation. A known volume of standard stock solution was added to the flask containing pre analyzed sample solution. The recovery of added standard drug was studied at three different levels. Each level was repeated five times. Readings were taken and shown in Table no. 2.

RESULTS AND DISCUSSION:

UV Scan of Choline Bitartrate in bulk Showed λmax value at 208nm in 10 µg/ml concentration. Beers range were performed to obtain linearity between 5-35 µg/ml, results were shown in Graph no.1. Assay of Choline Bitartrate using UV Spectrophotometry at maximum absorbance at 208 nm gives precise and accurate results for amount present in tablet formulation.

CONCLUSIONS:

The proposed method for Choline Bitartrate have many advantages over other analytical methods due to its lower cost, convenient method and environmental safety. Economically compared to other analytical methods, this method can be extended for the routine assay of Choline Bitartrate and its formulations. The low value of standard deviation and co efficient of variation indicates that the proposed method is accurate, precise and reproducible.

Table no.1 Assay of Choline Bitartrate in Tablet Formulation

Sl. No.	Weight of sample taken (mg)	Absorbance	Amount present in mg/tablet	% of drug content	Standard division	Co efficient of variance
1	156.9	0.1926	540	98.1%	0.547	98.1%±0.10%
2	157.0	0.1928	540	98.1%
3	157.2	0.1931	541	98.3%
4	157.3	0.1931	540	98.1%
5	157.5	0.1934	541	98.3%

Table no.2 Recovery Studies

Sl. No.	Formulation	Amount of Standard added	Amount Found	% Recovery
1	Sample	8.0mg	7.5mg	94
2	Sample	15.0mg	15.0mg
3	Sample	28.0mg	22.5mg

ACKNOWLEDGEMENT:

The authors are thankful to the Founder Chairperson of Periyar College of Pharmaceutical Sciences, Trichy for extending Laboratory facilities to carry out this work.

REFERENCES:

1. Huang T et al ; Liq chromatography B 670 : 323 – 327 , 1995.

2. K Lein J et al ; Neurochem Int 22:293 – 300 , 1993.

3. Heilbronn E, and Carrisson, B., J. Chromatogr. 4, 257 – 259, 1960.

4. Kneczke M. J. Chromatogr 1980.

5. USP 30 – NF 25, 905 Pharmacopeial Forum No.30 (3) 950.

Received on 29.08.2012 Accepted on 20.10.2012

Asian J. Pharm. Ana. 2(4): Oct. - Dec. 2012; Page 114-115