DEVELOPMENT OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR THE DETERMINATION OF MONTELUKAST IN PHARMACEUTICAL DOSAGE FORMS
Background: A High-performance liquid chromatography (HPLC) method was designed for the analysis to determine Montelukast in phaermaceutical dosage form. The column chromatographic configurations comprised of a 250 X 4.6 mm column containing 5-µm; packing L1 (C18), along with mobile phase (Dissolve 0.68 gm of Potassium Dihydrogenphosphate (KH2PO4) with 250 ml of HPLC grade water, mix with 750 ml of HPLC grade Acetonitrile. Add 2 ml of Triethylamine with the above mixture and adjust pH to 6.0 with Phosphoric acid) and Pass the solution through 0.45µmembrane filter and degas) with flow rate of 2.0 ml/min. Montelucast sodium detection was performed at 220 nm. After analysis of three samples average content of Montelukast is 4.02 mg/tablet and Relative Standard Deviation (RSD) is 0.90%. As average assay result is satisfactory and RSD of average content of three samples is less than 2%, so results are very consistent and can be inferred that the analytical determination procedure is appropriate for routine analysis of this product after validation of this method.
Materials and Methods:
Materials: This HPLC Chromatographic analytical method development of Montelucast sodium uses materials of - 4.6 x 250 mm column containing 5 µm packing L1(C18), HPLC grade Acetonitrile, HPLC grade water, Potassium Dihydrogenphosphate (KH2PO4), Triethylamine, Phosphoric acid.
Methods: The analytical method development has been established through five (5) different experimental procedures which is briefly summerized below. In first step researchers tried to develop the method of analysis for Montelukast Tablet 4 mg as like as Montelukast sodium raw material/drug substance according to the literature review. In second step, the interference of impurities with active drug substance has been examined. In third step, the resolution between two (2) picks of Montelukast sodium and Montelukast sodium impurity - A has been determined. In fourth step interference of formulated placebo with active drug substance has been examined. In step five researchers evaluated the analytical procedure through analyzing the fininshed pharmaceutical dosage form of Montelucast Sodiaum 4 mg tablet.
Step-1: In this step, the Relative Standard Deviation (RSD) of conjugated five replicate injections was found 1.2% which is less than 2 and the average area of standard and sample were found very near about. Final computation shown satisfactory assay result of this product.
Step-2: In this step, the study results found that the retention time (RT) of Montelukast sodium and Montelukast Sodium impurity-A are not same. So, Montelukast sodium has no interference with Montelukast sodium impurity-A.
Step-3: In this step, it was observed that resolution of Montelukast sodium and Montelukast Sodium impurity-A above 2. So, this method of analysis ensure that it has a suitable resolution between two peaks.
Step-4: In this step, no remarkable peaks were found for placebo sample solution at the retention time (RT) of Montelukast Sodium and Montelukast Sodium impurity-A. So it is clear that there is no interference of placebo with Montelukast Sodium.
Step-5: In this step, three samples of Montelukast Sodium tablet has been examined and the average content of Montelukast is found 4.02 mg/tablet. The Relative Standard Deviation (RSD) is found 0.90% which is less than 2%.
Conclusion: Based on the laboratory experiments in different ways it is observed that there is no interference of impurities and placebo with Montelukast sodium. After analysis of three samples average content of Montelukast is found 4.02 mg/tablet and Relative Standard Deviation (RSD) is 0.90%. As average assay result is satisfactory and RSD of average content of three samples is less than 2%, so results are very consistent and can be inferred that the quantitative analytical process is suitable for routine analysis of this product after validation of this method.Keywords: Montelukast Sodium, High-Performance Liquid Chromatography, Analytical Method Development.