Abstract
APPROACH: The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method development in which the peaks will be appear with short period of time as per ICH Guidelines. A simple, rapid, and precise method was developed for quantitative analysis of Pioglitazone in bulk as well as in pharmaceutical dosage forms. SUMMARY: The chromatographic separation of Pioglitazone was achieved on an ODS C18 (4.6 x 150mm, 3.5µm) analytical column with Disodium Hydrogen Phosphate Buffer (pH adjusted to 4.0 by using Orthophosphoric Acid) & Acetonitrile [HPLC Grade] in the ratio of 30:70 (v/v), as mobile phase at ambient temperature. The flow rate was 1.0 ml/min and detection was by absorption at 318 nm using a PDA detector. The number of theoretical plates and tailing factor for Pioglitazone were 2016.823 and 1.52 respectively. The linearity of the method was excellent over the range 50–90 ppm for the drug Pioglitazone. The correlation coefficient was 0.9999. The relative standard deviations of peak areas from five measurements were always less than 2%. The LOD for Pioglitazone was found to be 0.063µg/ml. The LOQ for Pioglitazone was found to be 0.224μg/ml .The drug content formulations were quantified by using the proposed analytical method. CONCLUSION: The proposed method was found to be suitable and accurate for quantitative analysis of Pioglitazone. The proposed method was adequate sensitive, reproducible, and specific for the determination of Pioglitazone bulk as well as in its Pharmaceutical dosage form. The validation of method was carried out utilizing ICH-guidelines. The described RP-HPLC method was successfully employed for the analysis of pharmaceutical formulations containing the dosage form. The proposed method was simple, fast, Accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Overall the proposed method was found to be suitable and Accurate for the Quantitative determination of the drug in Pharmaceutical dosage form.
