Method Development and Validation of Amlodipine, Gliquidone and Pioglitazone: Application in the Analysis of Human Serum

Abstract

A sensitive LC method has been developed for the simultaneous determination of co-administered drugs amlodipine, gliquidone and pioglitazone in bulk drug, pharmaceutical formulations, and human serums. The assay involved an isocratic elution of analytes on a Purospher^® STAR RP-18 end capped (5 μm, 25 x 0.46 cm) column at ambient temperature with a mobile phase consisting of methanol: water: acetonitrile (80:10:10 v/v/v) at a flow rate of 0.7 mLmin^-1 at 230 nm. The pH was adjusted to 3.50 with phosphoric acid and glibenclamide was used as an internal standard. The linearity of the method was found to be 5-50 μgmL^–1 for all the drugs with correlation coefficients were 0.9991, 0.9992 and 0.9963; the limit of detection was found to be 0.34, 0.06 and 0.33 μgmL^–1 for amlodipine, gliquidone and pioglitazone, respectively. All the validated parameters were in the acceptable range. The recovery rates of drugs were 98.2-101.53 %, 100.40-101.60 % and 98.25-101.20 % in human serum for amlodipine, gliquidone and pioglitazone, respectively. This method is applicable for the analysis of drugs in bulk drug, formulations, serum and in clinical samples without interference from excipients or endogenous serum.

Key words:

• Amlodipine
• gliquidone
• pioglitazone
• HPLC
• method development