Analytical method development and validation of metoprolol succinate by high performance liquid Chromatography and Ultraviolet spectroscopy technique

Abstract

Metoprolol Succinate (MS) is a β 1-blocker and a drug of choice for a patient suffering from cardiovascular diseases. Referable to the highly probable over dosage, a rapid and easy to execute a method for the quantitative determination of MS in biologic matrices would be utilitarian in its therapeutic monitoring as well as in intoxication cases. The report presents two validated methods for detection of MS by UV-VIS and HPLC. The parameters targeted for the validation were: specificity, range, detection and quantification limits, accuracy, and precision and were determined according to International Conference on Harmonization ICH Q2 (R1) guidelines. HPLC was conducted on the Water Spherisorb® analytical column (5μm, 4.6 x 250mm). The mobile phase consisted of a buffer (ACN: orthophosphoric acid: water; pH 3.0) and the flow rate was maintained at 2.0ml/min. MS was monitored using the Water Breeze 2 system equipped with photodiode array detector (λ = 224nm) and also by a UV-VIS spectrophotometer (λ = 224nm) by Shimadzu UV 1800. Linearity was observed in concentration range of 10–50μg/ml by HPLC and 2–10μg/ml by UV spectroscopy method. The correlation coefficient was 0.9992 and 0.9998. All in all, the system suitability parameters were set up inside the range as per ICH. The performed method is rapid, cost-effective and can be used as a quality-control method for routine quantitative analysis of MS in pure and pharmaceutical dosage forms.