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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. ********************************************************************************************************************************************** RESULTS AND DISCUSSION: INTRODUCTION:

•Rosiglitazone, a thiazolidinedione derivative, is an oral anti-diabetic drug hat acts primarily by increasing insulin sensitivity at the level of target issues, including adipose and muscle tissue. It was approved by FDA in 2000 for the treatment of diabetes.1 Some analytical methods have been eported for the determination of rosiglitazone in human plasma2,3, but no method is available for the determination of rosiglitazone in bulk drug. OBJECTIVE: EXPERIMENTAL METHODS: 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. Scanning 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 . •Calibration curve of rosiglitazone in distill water: •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 . Mobile Phase: •HPLC was carried out on a reversed phase Kromasil 300-4 C18;250×4.0 mm I.D.) column with 5-μm particle size and equipped with Hitachi L-7110 pump, L-7400 UV detector and Winchrome-99 software 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 nm. The mobile phase was delivered at a flow rate of 1 ml/min.

As shown in figure 1, UV Visible spectrophotometry shows a clear peak at 316 nm with high sensitivity (concentration, 40 µ 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 µ 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 4.09±0.116. The calibration curves was linear with correlation coefficient were 0.997 as shown in figure 4.

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

Fig-3: Chromatogram (HPLC) of rosiglitazone

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

Fig-4: Calibration curve of rosiglitazone at 316 nm (HPLC)  

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.