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DEVELOPMENT OF UV VISIBLE SPECTROPHOTOMETRY AND HPLC

METHOD FOR ESTIMATION OF ROSIGLITAZONE IN BULK DRUG Patel RM1, Rajgor NB2* ,Patel HK

1, Patel VB11. Dharmaj Degree Pharmacy College, Near Amrapali Township, Dharmaj, Dist:Anand, Gujarat, INDIA

2.M.P. Patel College of Pharmacy, Jeevanshilp Education Trust, Garod road, Kapadwanj, Gujarat-387620, India.

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INTRODUCTION:

Rosiglitazone, a thiazolidinedione derivative, is an oral anti-diabetic drugat acts primarily by increasing insulin sensitivity at the level of target

ssues, including adipose and muscle tissue. It was approved by FDA in

000 for the treatment of diabetes.1 Some analytical methods have been

eported for the determination of rosiglitazone in human plasma2,3, but no

ethod is available for the determination of rosiglitazone in bulk drug.OBJECTIVE:

EXPERIMENTAL METHODS:

Scanning of rosiglitazone in UV Spectrophotometric Region:

100 mg of rosiglitazone was accurately weighed, dissolved in 5 ml of

thanol and volume was made up with distill water up to 100 ml to produce

tock solution (1 mg/ml). A standard solution having a concentration of 40

g/ml was prepared by appropriately diluting the stock solution. The

tandard solution was scanned between wavelength range of 200 to 400

m in Shimadzu UV spectrophotometer to determine the wavelength of

aximum absorbances .Calibration curve of rosiglitazone in distill water:

The stock solution of 1 mg/ml was prepared as describe above. Working

tandards ranging in concentration from 10-50 g/ml were prepared by

ppropriately diluting the stock solution. The absorbance was measured at

16 nm using a Shimadzu UV spectrophotometer using water as blank.

xperiments were done in triplicate.

Estimation of rosiglitazone in HPLC

Stock solution was prepared by accurately measuring 100mg of the

rug, dissolved in 5 ml of ethanol and volume was made to 100 ml bydding HPLC grade water. From this solution, working standards of 10- 50

g/ml were made by dilutions and area was noted in isocratic HPLC

ystem. The standard plot was obtained by plotting area against the

oncentration .

Mobile Phase:

HPLC was carried out on a reversed phase Kromasil 300-4

C18;2504.0 mm I.D.) column with 5-m particle size and equipped with

itachi L-7110 pump, L-7400 UV detector and Winchrome-99 software

as used. A mobile phase consisted of acetate buffer (80mM) and

cetonitrile (55:45v/v, pH 4.37) and the detection was carried out at 316m. The mobile phase was delivered at a flow rate of 1 ml/min.

RESULTS AND DISCUSSION:

As shown in figure 1, UV Visible spectrophotometry shows a clear peak at316 nm with high sensitivity (concentration, 40 g/ml) and also the

calibration curves was found to be linear with correlation coefficient of 0.999

over a concentration range of 10-50 g/ml (Figure 2).For HPLC method, the number of solvents were used for the selection of

mobile phase. Finally mobile phase consisted of acetate buffer (80mM) and

acetonitrile (55:45v/v, pH 4.37) was selected as a mobile phase. Figure 3

shows that chromatogram of rosiglitazone gives a clear sharp peak with

retention time of 4.090.116. The calibration curves was linear with

correlation coefficient were 0.997 as shown in figure 4.

CONCLUSION:

From the above results, we can conclude that both HPLC and UV Visible

spectrophotometry are sensitive, accurate and precise methods for the

determination of rosiglitazone in bulk drug.

REFERENCES:1. http://www.cdsco.nic.in/html/DRUGSAPRVD.htm

2. Hruska MW, Frye RF. Simplified method for determination of rosiglitazone

in human plasma, J Chromatogr. 2004; 803: 317-320.

3. Kolte BL, Raut BB, Deo AA, Bagool MA, Shinde DB. Liquid

chromatographic method for the determination of rosiglitazone in human

plasma. J Chromatogr 2003; 788: 37-44.

Fig-3: Chromatogram (HPLC) of rosiglitazone Fig-4: Calibration curve of rosiglitazone at

316 nm (HPLC)

Fig-1: UV absorption spectrum of rosiglitazonein water. (200-400 nm range).

Fig-2: Standard plot of rosiglitazone in 0.9%NaCl (UV)

The objective of the present work was to develop the simple,accurate, precise and reliable analytical method for the estimation of

rosiglitazone in bulk drug through UV Visible Spectrophotometry and

HPLC method.

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