NON-DESTRUCTIVE RAMAN SPECTROSCOPIC METHOD FOR ESTIMATION OF MONTELUKAST FROM TABLET DOSAGES FORM

Objective: A rapid, non-destructive and non-solvent raman spectroscopic method for estimation of Montelukast from tablet dosages form Methods: Quantification was carried out by measuring the intensity of analyte peak at 1440 cm-1. Each Raman spectrum corresponded to an accumulation of 4 scans with an exposure time of 5 sec for each scan with a total integration time of 20 sec.Results: The method exhibited linearity between 2 mg-24 mg show well resolve quantification From MON. The linearity equation was calculated as y = 13.036x+70.819 and the correlation coefficient was found to be 0.997 for MON. LOD (limit of detection) and LOQ(limit of quantification) values were calculated using the calibration curve slope and standard deviation of the response. The LOD (limit of detection) and LOQ (limit of quantification) values were found to be 1.71 mg and 5.13 mg respectively.Conclusion: The developed method was successfully applied for assay of montelukast in the intact formulation. The method was validated according to an international conference on harmonisation guidelines. A recent study, montelukast sodium had been analysed by the raman method, but, looking into the tremendous potential of raman spectroscopic method; it can be extended as a process analysis and technology tool in various quality checks during manufacturing of pharmaceutical products

RP-HPLC METHOD FOR ESTIMATION OF TIAPRIDE RELATED SUBSTANCE IN TABLET FORMULATION

Objective: To develop a simple, precise, accurate related substance, reverse phase high-performance liquid chomatographic (RP-HPLC) method for the quantitative estimation of impurities which are present in dosage form of Tiapride Hydrochloride.Methods: The chomatographic separation was achieved with Inertsil C8 (250 × 4.6) mm, 5µ column with mobile phase containing a gradient mixture of 0.05 mM aqueous sodiumdihydrogen phosphate (KH2PO4)solution buffer: (with octanesulphonate and final pH of buffer was adjusted to 2.7 with Orthophosphoric acid): Acetonitrile: Methanol (800:150:50 v/v), flow rate of 1.5 ml/min and a detection wavelength of 240 nm.Results: The method exhibited linearity between range 0.125 to 1200 µg/ml, shows well resolved degradation products from Tiapride hydrochloride tablet with 0.063 µg/ml of LOD (limit of detection) and 0.125 µg/ml of LOQ (limit of Quantification). Forced degradation studies proved that the method is specific for Tiapride Hydrochloride and N-oxide Tiapride reported in European pharmacopeia and British pharmacopeia is one of the degradation impurity confirmed by liquid chromatography mass spectrometry (LC-MS) analysis.Conclusion: An accurate, precise, linear, robust and specific related substance RP-HPLC method was developed and validated for the quantitative estimation of impurities presented in pharmaceutical dosage form of Tiapride Hydrochloride as per ICH guidelines. The method is stability indicating used for separation of degradation products and can be used for the identification of process related impurity.Â