STABILITY INDICATING CHIRAL HPLC METHOD FOR THE ESTIMATION OF PIOGLITAZONE ENANTIOMERS IN PHARMACEUTICAL FORMULATION

Objective: A stability indicating chiral high performance liquid chromatographic (HPLC) method was developed and validated for the separated (S)and (R) pioglitazone in raw material and its determination in the presence of degradation products formed during forced degradation studies.Methods: In the present study, an isocratic normal phase-HPLC method was developed with stationary phase as ACI Cellu 1 (150 mm × 4.6 mm i.d.,5  μ)  column  and  n-hexane:  N-propyl  alcohol  (80:20,  V/V)  as  mobile  phase.  The  entire  study  was  performed  using  1.0  ml/minute  as  flow  rate  and the detection wavelength at  233 nm. The pioglitazone (R and S) was exposed to various stress condition such as hydrolytic (acid and base), neutral, oxidative, and photolytic. The stressed samples were analyzed by the proposed method.Result:  The  described  method  was  linear  over  the  range  of  5-15 µg/ml  for  R-pioglitazone  and  4-14 µg/ml  for  S-pioglitazone.  The  limit  of  detection and limit of quantification of S-pioglitazone and R-pioglitazone were found to be 1.4 μg/ml and 4.26 μg/ml, respectively. The recovery study of S and R-Pioglitazone from tablets formulation ranged from 97.14% to 100.04%, respectively.Conclusion: The developed method can be applied in the quality control of drug products.Keywords: Stability-indicating method, Validation, Chiral, Pioglitazone