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DEVELOPMENT OF UV VISIBLE SPECTROPHOTOMETRY AND HPLC

METHOD FOR ESTIMATION OF ROSIGLITAZONE IN BULK DRUG


Patel RM1, Rajgor NB2* , Patel HK1, Patel VB1
1. 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: RESULTS AND DISCUSSION:
•Rosiglitazone, a thiazolidinedione derivative, is an oral anti-diabetic drug
As shown in figure 1, UV Visible spectrophotometry shows a clear peak at
hat acts primarily by increasing insulin sensitivity at the level of target
316 nm with high sensitivity (concentration, 40 µ g/ml) and also the
issues, including adipose and muscle tissue. It was approved by FDA in
calibration curves was found to be linear with correlation coefficient of 0.999
2000 for the treatment of diabetes.1 Some analytical methods have been
over a concentration range of 10-50 µ g/ml (Figure 2).
eported for the determination of rosiglitazone in human plasma2,3, but no
For HPLC method, the number of solvents were used for the selection of
method is available for the determination of rosiglitazone in bulk drug.
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
OBJECTIVE:
shows that chromatogram of rosiglitazone gives a clear sharp peak with
EXPERIMENTAL METHODS: retention time of 4.09±0.116. The calibration curves was linear with
correlation coefficient were 0.997 as shown in figure 4.
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
Scanningmethod.
of rosiglitazone in UV Spectrophotometric Region:
•100 mg of rosiglitazone was accurately weighed, dissolved in 5 ml of
ethanol and volume was made up with distill water up to 100 ml to produce
stock solution (1 mg/ml). A standard solution having a concentration of 40
µ g/ml was prepared by appropriately diluting the stock solution. The
standard solution was scanned between wavelength range of 200 to 400
nm in Shimadzu UV spectrophotometer to determine the wavelength of
maximum absorbances . Fig-1: UV absorption spectrum of rosiglitazone Fig-2: Standard plot of rosiglitazone in 0.9%
•Calibration curve of rosiglitazone in distill water: in water. (200-400 nm range). NaCl (UV)

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


standards ranging in concentration from 10-50 µ g/ml were prepared by
appropriately diluting the stock solution. The absorbance was measured at
316 nm using a Shimadzu UV spectrophotometer using water as blank.
Experiments were done in triplicate.
Estimation of rosiglitazone in HPLC
•Stock solution was prepared by accurately measuring 100mg of the
drug, dissolved in 5 ml of ethanol and volume was made to 100 ml by
adding HPLC grade water. From this solution, working standards of 10- 50
µ g/ml were made by dilutions and area was noted in isocratic HPLC
system. The standard plot was obtained by plotting area against the
concentration . Fig-3: Chromatogram (HPLC) of rosiglitazone Fig-4: Calibration curve of rosiglitazone at
316 nm (HPLC)
Mobile Phase:  
CONCLUSION:
•HPLC was carried out on a reversed phase Kromasil 300-4 From the above results, we can conclude that both HPLC and UV Visible
C18;250×4.0 mm I.D.) column with 5-μm particle size and equipped with spectrophotometry are sensitive, accurate and precise methods for the
Hitachi L-7110 pump, L-7400 UV detector and Winchrome-99 software determination of rosiglitazone in bulk drug.
was used. A mobile phase consisted of acetate buffer (80mM) and
acetonitrile (55:45v/v, pH 4.37) and the detection was carried out at 316  REFERENCES:
nm. The mobile phase was delivered at a flow rate of 1 ml/min. 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.

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