Pharmaceutical Methods
Publishing Quality Research & Reviews
Pharmaceutical Methods
Publishing Quality Research & Reviews
Author(s): Alankar Shrivastava, and Prachi Saxena
Background: Stability Indicating Method (SIM) is a quantitative analytical procedure used to detect a decrease in the amount of the active pharmaceutical ingredient (API) present due to degradation. According to Food and Drug Administration (FDA) guidelines, an SIM is defined as a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from potential interferences, such as degradation products, process impurities, excipients, or other potential impurities, and the FDA recommends that all assay procedures for stability studies be stability indicating. Here in this study we developed simple precise and accurate stability indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) assay to analyze capsaicin (CAP) at concentrations from 70 to 130 μg/mL. Materials and Methods: HPLC equipped with Photo diode Array (PDA) detector, Pump model 600E of Waters and Empower software. Column used for the separation is ODS (250 × 4.6 mm) with particle size 5 μm and all the reagents and water were of HPLC grade. Results: The chromatographic separation was carried out using mobile phase Acetonitrile (ACN):water:buffer::75:10:15 with a flow rate of 1 mL/min on a C18 column. The concentration of the eluting compounds was monitored by a UV detector at 280 nm. No interferences were observed when stress conditions were applied and analyzed. Linearity was established using visual method, residuals plot, Dixon, and lack of fitness test. Limit of detection and limit of quantification was found to be 52.9 and 160 ng/mL, respectively. Recovery studies prove this method as useful in recovering the analytes. Relative Standard Deviation (RSD) of inter- and intraday precision within the acceptable limit of 2% proves that this method is precise. No degradation was found with alkaline conditions, thermal and photodegradation. Conclusions: This study can be used for successful separation of CAP and its potential degradants in bulk and formulations. UV spectra of one of the degradants are also presented here and can be the basis to generate chemistry of potential degradants when CAP is kept under environmental conditions.
