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Single and high resolution RP-HPLC method for the determination of six anti diabetic drug products

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Author(s): Useni Reddy Mallu1, Viswanath Reddy Pyreddy1, Somasekhar Penumajji 2 and Varaprasad Bobbarala3

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 4;
Start page: 1209;
Date: 2011;
Original page

Keywords: Metformin Hydrochloride | Pioglitazone | Glipizide | Gliclazide | Glibenclamide | Glimepiride | HPLC method development and anti diabetic drug products

ABSTRACT
OBJECTIVE: To develop a single RP-HPLC method for the simultaneous determination of six active ingredients including Metformin Hydrochloride, Pioglitazone, Glimepiride, Gliclazide, Glibenclamide and Glipizide in pharmaceutical products.METHOD: HPLC analysis was carried out by using a C18 (150mm, 4.6mm and 3μ) column with the gradient mobile phase composed of Sol-A: phosphate buffer (1.0g of KH2PO4 in to 1000ml of HPLC water, mix and adjusted the pH to 3.0 with diluted H3PO4) and sol-B: acetonitrile with simple gradient program (0-4min, sol-A:65-65; 4-8min- sol-A:65-43; 8-15min- ol-A:43-38; 15-20min- sol-A:38-40; 20-22min- sol-A:40-65 and 22-25min- sol-A:65-65). Flow for mobile phase elution is 0.6ml permin; column oven temperature is maintained at 35°C and measured the absorbance at 210nm.RESULT: Metformin Hydrochloride, Pioglitazone, Glipizide, Gliclazide, Glibenclamide and Glimepiride were eluted at 2.2min, 7.5min, 11.4min, 14.5min, 16.7min and 17.9min, respectively. Percent relative standard deviation for five replicate standard injections area is below 1.0percent. The method was validated with specificity, precision, linearity, accuracy, ruggedness and robustness. The response was linear over the concentration range of 10 to 60 μg per mL for each ingredient, with correlation coefficients value is greater than 0.999. Recovery results were between 98 percent to 102 percent. CONCLUSION: This RP-HPLC method is simple, single and reproducible, with high resolution and has been successfully applied for the simultaneous determination of the six components (Metformin Hydrochloride, Pioglitazone, Glipizide, Gliclazide, Glibenclamide and Glimepiride) in pharmaceutical drug products

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