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RP-HPLC Method Development and Validation for the Determination of Pioglitazone HCl and its forced degradation studies
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| Author:
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AMPATI SRINIVAS, ALEKYA, AGAIAH GOUD
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| Abstract:
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The present paper describes the simple, precise cost effective Reverse Phase high performance liquid chromatographic (RP-HPLC) method for the determination of Assay of Pioglitazone hydrochloride. The active pharmaceutical ingredient (API) of Pioglitazone hydrochloride was subjected to stress conditions viz., hydrolysis, oxidation, photolysis and thermal degradation. The drug was found to be sensitive under basic and oxidation environment. Chromatographic separation was achieved on a Develosil ODS C18 RP Column, 250 mm x 4.6 mm, 5?m using a mobile phase consisting a mixture of Buffer (0.05 M potassium dihydrogen phosphate & pH adjusted to 3.1 with orthophosphoric acid) and Acetronitrile in a ratio of 40:60 at a flow rate of 1.0ml/min. The detection was made at 226nm. The retention time of Pioglitazone hydrochloride was found to be 2.85 minutes. The method was found linear over the range of 5-35%.The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation and robustness. As the proposed method could effectively separate the drug from its impurities, it can be employed as stability-indicating method for the determination of instability of this drug in API samples of Pioglitazone hydrochloride.
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| Keyword:
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Pioglitazone hydrochloride, RP-HPLC, Stability studies, development, validation, forced degradation
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| EOI:
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| DOI:
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