Development and Validation of Stability Indication Method For Estimation of ANTI Diabetic Drugs

Abstract

OBJECTIVES: newlineSeveral combinations like Anagliptin (ANA) and Metformin (MET); Metformin and Miglitol (MIG); and Anagliptin and Miglitol are chosen combinations for treatment of diabetus mellitus according to guidelines like ICMR and Indian guidelines of diabetus. The objective is to develop and validate simple, accurate, sensitive and rapid UV, HPTLC and Stability indicating RP-HPLC method for estimation of individual drugs in selected combinations in bulk, pharmaceutical and simulated dosage form and to do statistical comparison of developed methods in terms of assay. newlineEXPERIMENTAL WORK: newlineand#61623; Spectrophotometric method (Q- Absorption Ratio Method): In this method, the concentration of the drugs was determined by using ratio of absorbance at iso-absorptive point (and#955;1= 238 nm) and at the and#955;max of Metformin HCl (and#955;2 = 233 nm). newlineand#61623; Spectrophotometric method (Second Derivative Method): In this method, ANA was estimated at 244 nm which was ZCP of MET. MET was estimated at 234 nm at which was ZCP of ANA. newlineand#61623; Spectrophotometric method (Simultaneous Equation Method): In this method, ANA and MET showed maximum absorbance at 247 (and#955;1) nm and 233 (and#955;2) nm respectively. newlineand#61623; Stability indicating RP-HPLC Method for simultaneous estimation of ANA and MET: In RP-HPLC method, separation was achieved by ZORBAX RX C8 (250 mm × 4.6 mm id, 5 and#956;m particle size) column using Potassium Dihydrogen Phosphate Buffer pH 2.7: Acetonitrile in starting ratio of 15:85% v/v as the mobile newlinephase with detection wavelength of 245 nm. newlineand#61623; Stability indicating high performance thin layer chromatography for estimation of ANA and MET in bulk and pharmaceutical dosage form: Chromatographic newlineseparation was carried out on Merck TLC Aluminium plates precoated with silica gel 60 F254 of size (20 cm x 10 cm) with 250 and#956;m layer thickness with the mobile phase Toluene: 1% Methanolic ammonium acetate (2:4 %V/V) at detection wavelength 243 nm for ANA and MET. newline