Abstract

STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION OF MESALAMINE

Shaikh Sirajuddin S.*, Alifiya S. Rajkotwala, Dr. Ronak R. Dedania,
Dr. Zarna R. Dedania and Dr. S. M. Vijendraswamy

ABSTRACT

Development of simple, accurate, precise, specific, and robust HPTLC method for the determination of Mesalamine. Methanol used as a solvent. The stock solution of Mesalamine was prepared using Methanol and subsequent dilutions were done by Methanol. The absorption-maxima for standard solution of Mesalamine was found at 230 nm. Simple extraction method was used to prepare sample. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity, robustness, ruggedness and solution stability. The linearity was studied in the concentration range of 500-2500ng/band with correlation coefficient 0.995 at 230 nm. The limit of detection and limit of quantification were found to be 105.68ng/band and 320.24ng/band respectively. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120 %. The % recovery was found to be in the range 98.51-101.23%. The low values of % relative standard deviation (RSD) are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % RSD value less than 2 indicate that the method is precise. The above method was a proved to be cost-effective quality-control tool for analysis of Mesalamine.

Keywords: Mesalamine, HPTLC, Stress Study, Stability Indicating Method.