Development of analytical method and its validation in bilayer tablet containing fexofenadine hydrochloride (immediate release layer) and montelukast sodium (sustained release layer) was written by Thakur, Sourav;Singh, Bhupendra;Vyas, Manish;Saini, Geetanjali;Yadav, Ravi Shankar;Khatik, Gopal;Chaudhary, Amit;Sharma, Neha. And the article was included in Asian Journal of Pharmaceutics in 2019.COA of Formula: C32H40ClNO4 This article mentions the following:
Aim: The aim of the present study was to develop and validate the anal. method for bilayer tablets. Materials and Methods: Simultaneous estimation of fexofenadine hydrochloride (HCl) and montelukast sodium in bilayer tablets by UV spectrophotometric method. Results and Discussion: The absorption maxima of fexofenadine HCl and montelukast sodium were found to be 259 nm and 285 nm, resp., using phosphate buffer pH 6.8. The method obeys Beer’s law in the concentration range of 24-84渭g/mL and 2-14渭g/mL for fexofenadine HCl and montelukast sodium, resp. Different anal. parameters such as limit of detection, limit of quantitation, accuracy, and precision were determined as per International Council for Harmonisation guidelines Q2 (R1). Conclusion: The accuracy of the method was found to be 99.71% and 99.13% for fexofenadine HCl and montelukast sodium, resp. There is no interference shown by the excipients of the formulation in the method and the method can be used for routine quality control. In the experiment, the researchers used many compounds, for example, 2-(4-(1-Hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic acid hydrochloride (cas: 153439-40-8COA of Formula: C32H40ClNO4).
2-(4-(1-Hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic acid hydrochloride (cas: 153439-40-8) belongs to piperidine derivatives. Piperidine is a saturated organic heteromonocyclic parent, an azacycloalkane, a secondary amine and a member of piperidines. Some chemotherapeutic agents have piperidine moiety within their structure, foremost among them, vinblastine and raloxifene.COA of Formula: C32H40ClNO4
Referemce:
Piperidine – Wikipedia,
Piperidine | C5H11N – PubChem