RP-LC

The concept of "Quality by Design" (QbD) is getting popularized in pharmaceutical manufacturing industry to understand the product and process to identify the risks involved during manufacturing.  One of the perpetual quality attribute is to have robust analytical method that can provide consistent results though out the life cycle of the product. General considerations during analytical method validation is to perform robustness studies by deliberate changes made in pH of the buffer in mobile phase, change in organic ratio, change in column oven temperature, change in buffer strength and using different column lot numbers etc. However to improve the analytical quality standard, a novel method concept under QbD was introduced which uses single mobile phase for three drug components and estimates using different column chemistries used in pharmaceutical industry viz., C18, C8, phenyl and Cyano column. The validated RP-LC method was successfully applied to the quantitative determination of Chlorpheniramine, Ibuprofen and Pseudoephedrine in tablet dosage form, helping to improve quality control and to assure therapeutic efficacy using all column chemistries.

An isocratic reverse phase liquid chromatography (RP-LC) method has been developed and subsequently validated for the determination of Lacosamide in Bulk and its pharmaceutical formulation. Separation was achieved with a Xterra RP-8 ((Make: Waters Corporation; 150 mmx4.6 mm I.D; particle size 5 µm)) Column and Sodium di-hydrogen phosphate monohydrate buffer (pH adjusted to 3.0 with diluted orthophosphoric acid): Acetonitrile (800:200) v/v as eluent at a flow rate of 1.0 ml/min. UV detection was performed at 230nm. The method is simple, rapid, and selective. The described method of Lacosamide is linear over a range of 12.0µg/ml to 37.85 µg/ml. The method precision for the determination of assay was below 1.0%RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 99.3 to 100.9%. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of Lacosamide in bulk, its dosage forms. Key Words: Lacosamide, RP-LC, Validation, Dosage form.