DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF PRANLUKAST HYDRATE IN ITS SYNTHETIC MIXTURE

Gajanan G. Kalyankar*, Priti. H. Vansiya, Kunjan B. Bodiwala, Sandesh R. Lodha, Pintu B. Prajapati, Shrikant V. Joshi

ABSTRACT

Accurate, precise and robust UV spectrophotometric method has been developed and validated for the estimation of Pranlukast Hydrate in its synthetic mixture. UV-spectrophometric determination was carried out at an absorbance maxima of 262 nm using ethanol as solvent. Developed method has been validated for linearity range, precision, accuracy, limit of detection, and limit of quantification as per ICH Q2(R1) guidelines. Linear regression analysis data for the calibration plots showed a good linear relationship with R2 of 0.9984 for Pranlukast hydrate in concentration range of 10-50 μg/ml. The intraday and interday precision of the method in terms of % RSD were found to be 0.66-1.21 % and 0.81-1.33 % respectively. LOD for Pranlukast hydrate was found to be 0.49μg/ml, while LOQ was found to be 1.51μg/ml. %Recovery of Pranlukast hydrate was found in range of 98-100.1 %. The method was applied to synthetic mixture for analysis of Pranlukast hydrate. The assay result was found to be in good agreement with amount of Pranlukast hydrate present in synthetic mixture.

Keywords: Pranlukast hydrate, Spectrophotometric Method, Synthetic Mixture, Validation.