Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY STABILITY INDICATING HPLC METHOD OF ANALYSIS FOR ASSAY OF MISOPROSTOL IN MISOPROSTOL TABLETS

K. J. Suthar*, V.T. Chudasama, M. K. Patel and B. S. Rajpurohit

ABSTRACT

A simple, economic, sensitive, precise, efficient HPLC method was developed and validated for the quantitative estimation Misoprostol in their pharmaceutical dosage form. The chromatographic separation was performed using, Thermo MOS Hypersil, 150x4.6mm, 5μ column. The mobile phase composed of 800 volumes of methanol, 700 volumes of water and 500 volumes of Acetonitrile at a flow rate of 1.0 mL/min and column temperature was maintained at 30°C. Quantitation was achieved with UV detection at 200 nm. The method was validated for specificity, linearity, precision, accuracy and robustness. The linear regression analysis data, Limit of Detection values, Limit of Quantitation values and Percentage RSD of Misoprostol were found under acceptance criteria. Statistical analysis data confirms that the method is repeatable and selective for the estimation of Misoprostol in bulk and in their pharmaceutical dosage form.

Keywords: HPLC, Misoprostol, Validation.