Abstract

TO STUDY THE PHYSICOCHEMICAL CHARACTERIZATION AND DRUG–EXCIPIENT COMPATIBILITY OF RANOLAZINE FOR THE DEVELOPMENT OF A STABLE PHARMACEUTICAL FORMULATION

Mayuri Papalal Pol*, Dr. Ankit Singh, Dr. Dhananjay M. Patil

ABSTRACT

In situ gel drug delivery systems have attracted considerable interest in recent years due to their ability to provide sustained drug release, enhanced bioavailability, prolonged gastric residence time, and improved patient compliance. The present study was aimed at performing preformulation characterization and drug–excipient compatibility evaluation of Ranolazine for its application in gastro-retentive in situ gel formulation. Preformulation studies including organoleptic evaluation, pH determination, melting point analysis, and solubility studies were conducted to assess the physicochemical properties of the drug. Ranolazine exhibited a near-neutral pH, indicating good aqueous stability. The melting point analysis confirmed the crystalline nature and purity of the drug sample. Solubility studies revealed that Ranolazine was freely soluble in methanol, soluble in ethanol, sparingly soluble in acetone, and slightly soluble in distilled water, highlighting the need forformulation strategies to improve aqueous solubility. Ultraviolet–visible spectrophotometric analysis was performed to determine the maximum wavelength of absorption (λmax), which was found to be 272 nm in 0.1 N hydrochloric acid. Calibration curves prepared in 0.1 N HCl and phosphate buffer pH 6.8 demonstrated good linearity with high correlation coefficients, confirming the reliability and accuracy of the developed analytical method for quantitative estimation. Fourier Transform Infrared (FTIR) spectroscopy was employed to characterize the functional groups of Ranolazine and to investigate its compatibility with selected excipients such as pectin and HPMC K4M. The FTIR spectra of drug–excipient physical mixtures showed no significant peak shifting, disappearance, or formation of new peaks, indicating the absence of chemical interactions. Overall, the findings of this study confirmed the chemical stability and compatibility of Ranolazine with selected excipients, thereby supporting its suitability for further development of gastro-retentive in situ gel drug delivery systems.

Keywords: Ranolazine, In situ gel, Preformulation studies, Drug–excipient compatibility, FTIR spectroscopy, UV spectrophotometry, Gastro-retentive drug delivery, Sustained release.