CHIRAL STABILITY INDICATING HPLC METHOD FOR ANALYSIS OF PIOGLITAZONE IN
PHARMACEUTICAL FORMULATION
B. Gowramma, S. N. Meyyanathan, N. Krishnaveni, B. Babu and B. Suresh
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, (A Constituent college of JSS
University, Mysore), Udhagamandalam – 643001 (Tamilnadu), India
Abstract:
A stability indicating chiral high performance liquid chromatographic (HPLC) method was developed and validated for the separation and determination of R and S pioglitazone in raw material in the presence of degradation products formed during forced degradation studies. An isocratic NP-HPLC method was developed with an ACI Cellu 1 (150 x 4.6 mm i.d., 5 μ) column and n-hexane: n-propyl alcohol (80:20, v/v) as mobile phase, the flow rate was 1.0 ml/min and at the wavelength of 233 nm. Typical retention times of R and S pioglitazone were about 3.6 min and 4.6 min, respectively. The Pioglitazone was subjected to stress conditions of degradation including hydrolysis, oxidation, photolysis and thermal degradation. The described method was linear over the range. Mild degradation was observed in alkaline but the drug was stable to photolysis. The developed method was validated with respect to linearity, precision, accuracy, ruggedness and specificity.