RP-UPLC and Stability Indicating

A new selective, sensitive and Rapid Reverse phase-UPLC method was developed and validated to determine the known potential impurities present in Telmisartan (TL) and Hydrochlorothiazide (HC) in fixed dose combination drug product. The quantification was carried out by using Acquity UPLC, HSS T3 (100 × 2.1) mm, 1.8m column, with a flow rate of  0.5mL/min at 225 nm .The mobile phase consists of 0.1% ortho phosphoric acid pH adjusted to 2.6 with diluted sodium hydroxide as Mobile phase A and acetonitrile as Mobile phase B. Separation of the impurities was achieved within 10.0 minutes of run time. Typical retention times of TL and HC were found to be about 5.4 and 2.0 minutes respectively. The product was subjected to various degradation conditions and validated in terms of linearity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines. The known impurities quantified in this study were HC imp-1 to 4 for Hydrochlorothiazide and TL imp-1 to 6 for Telmisartan. Recovery was established for all the impurities with respective to LOQ to 150%. The data supports that the newly developed method is capable to determine all the potential impurities of TL and HC.

This paper describes a strategy for the systematic development and validation of stability-indicating method of the determination of degradation impurities present in Naftopidil Orally dispersible tablets.  Efficient separation is achieved in 75mm length x 2.1mm ID, Octadecyl column with 3µ particle size. Using pH 3.2 phosphate buffer and acetonitrile as mobile phase in gradient pump mode. Flow rate was selected 0.4mL.min-1with a detection wavelength of 210nm. Validation parameters such as specificity, linearity, precision, accuracy, determination of LOD,  LOQ and robustness were evaluated as per ICH guidelines. The validated Reverse phase –Ultra Performance liquid chromatography (RP-UPLC) method was successfully applied to the quantitative determination of impurities of Naftopidil in Naftopidil Orally Dispersible tablet dosage forms, helping to improve quality control and to assure therapeutic efficacy at reduced run time of minutes.