Abstract
Objective: The aim of the research work to develop a simple, sensitive, rugged, robust and specific novel gradient stability indicating reverse phase HPLC method for quantitative determination of known and unknown impurities profiling of Carvedilol pharmaceutical dosage forms (Tablets).
 Methods: Chromatographic separation has been achieved on an Inertsil ODS 3V column (150 mm x 4.6 mm, 5μm) with mobile phase consisting Mobile phase-A (Water, Acetonitrile and Trifluroacetic acid in the ratio of 80:20:0.1 v/v/v respectively and pH adjusted to 2.0 with dilute potassium hydroxide solution) and Mobile phase-B (Water and acetonitrile in the ratio of 100:900 v/v respectively) delivered at flow rate of 1.0 ml min-1 and the detection wavelength 240 nm. The column compartment temperature maintained at 40 °C.
 Results: Resolution between Carvedilol and its impurities has been achieved greater than 1.5. The developed method was validated as per ICH guidelines. Analytical method found Precise, Linear, accurate, specific, rugged and robust.
 Conclusion: Developed and validated novel analytical method can be used to for impurity profile analysis of Carvedilol Pharmaceutical dosage form (Tablets).
Highlights
Carvedilol chemically it is named, (±)-1-(carbazol-4-yloxy)-3-((2-omethoxyphenoxy) ethyl) amino)-2-propanol
Carvedilol and its known impurities wavelength scan was performed and impurities shows maximum response at 240 nm wavelength, this wavelength is chosen for final quantification of impurities
The development of the method began with the purpose of separating all known, unknown and degradents impurities that are generated during stability
Summary
Carvedilol chemically it is named, (±)-1-(carbazol-4-yloxy)-3-((2-omethoxyphenoxy) ethyl) amino)-2-propanol. Carvedilol shows a greater antioxidant activity than other commonly used beta-blockers [3, 4]. It has been prescribed as an antihypertensive agent, an antiangina agent [5,6,7,8]. Impurity profiling (known and unknown), generation of degradents and identification of degradents of active pharmaceutical ingredients (API) and pharmaceutical dosage form (tablets) is one of the most challenging tasks to pharmaceutical analytical scientists in pharma industry [10]. All drug regulators in different countries have established maximum permissible limits for known and unknown impurities both in Active Pharmaceutical Ingredients and pharmaceutical dosage forms [11, 12]. All the major international pharmaceutical regulators require that the study of known and unknown impurities profiles of drug substances and drug products be performed using a suitable stability indicating validated analytical method [13,14,15,16,17]
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