A Stability Indicating Assay Method Development and Validation for the Frovatriptan Succinate Monohydrate by Using UV: A Spectrophotometric Technique

A new simple, reliable, inexpensive, and accurate method was developed for the quantification of Frovatriptan Succinate Monohydrate in different physiological media at 244？nm in bulk and in tablet dosage forms. The developed method is an attempt to surpass the disadvantages associated with the reported methods, namely, less sensitive and tedious in usage for routine purposes. Beer’s law was followed over the range of 1.0？μg/mL to 4.5？μg/mL. Stability indicating assay method was developed and validated as per the ICH guidelines using various parameters, for example, accuracy, precision, limit of quantification, limit of detection, robustness, ruggedness, solution stability, recovery, forced degradation (hydrolysis, photo degradation, thermal degradation, and oxidation), and so forth. Percent relative standard deviation associated with all the parameters was less than 2, showing compliance with the acceptance criteria of ICH guidelines. The developed method was very sensitive as limit of quantification and limit of detection were found to be 0.025？μg/mL and 0.00625？μg/mL, respectively. Forced degradation studies of drug reveal good stability under the chosen experimental conditions. 1. Introduction Chemically, the Frovatriptan Succinate Monohydrate (FSM) is 3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole succinate monohydrate (Figure 1). It is a potent and selective agonist of 5-HT1B and 5-HT1D receptors. By acting on 5-HT1B receptor, it causes constriction of dilated arteriovenous anastomoses. The action on 5-HT1D causes the inhibition of Substance and calcitonin gene-related peptide (CGRP) release. Among all the triptans, it has the longest elimination half-life ( 1/2) of 26 hours. This carabzole derivative was approved by FDA in 2001. It has all the ideal characteristics to be used as a first line drug for menstruation migraine [1–3]. Figure 1: Structure of Frovatriptan Succinate Monohydrate (FSM). Despite tremendous utility of FSM in migraine, there was no simple, sensitive, and reliable stability indicating that UV spectroscopic method has been reported for its analysis in the vast reviewed literature. Only two UV spectroscopic methods have been mentioned in the literature for the analysis of FSM in 0.1？N NaOH and 0.1？N HCl at 280.2？nm and 279？nm, but these methods are less sensitive and tedious to be used for routine purposes because they involve first-order derivatization, second-order derivatization, and area-under the-curve (AUC) analysis in order to make their method sensitive [4, 5]. HPLC methods were reported in the literature for