Development of Stability Indicating Robust Chromatographic Method for the Simultaneous Estimation of Cinnarizine and Dimenhydrinate in Dosage Form
Keywords: Cinnarizine, Dimenhydrinate, Full factorial design, Quality by Design (QbD), Response surface methodology (RSM), Ultra-performance liquid chromatographic (UPLC).
AbstractEstimation of Cinnarizine (CNN) and Dimenhydrinate(DMH) was carried out using a stability-indicating method using ultra-performance liquid chromatographic (UPLC). Both the drugs have pKa values, 8.4 for Cinnarizine and 8.8 for Dimenhydrinate, resulting in a challenge for chromatographic method development with poor resolution. Design of experiment with full factorial 23 design facilitated optimization of various method parameters like Mobile phase pH, column temperature, and flow rate as these are critical factors for the best resolution between Cinnarizine and Dimenhydrinate. The separation was achieved with a simple gradient method using a 50 mm x 4.6 mm, 3.5 μm, column (Waters, X-bridge C-18) with 0.3 mL/min as flow rate, column temperature set at 40°C, and wavelength for analysis selected was 260 nm. The method fulfi lled the validation criteria as per ICH guidelines. The method was linear within concentration range of 10 to 150 μg.mL-1 for Cinnarizine and 20 to 300 μg mL-1 for Dimenhydrinate. The chromatographic peak purity in the degradation study revealed no co-eluting peaks and standard Cinnarizine and Dimenhydrinate. The method can successfully quantify the drugs in the commercially available dosage form.
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