The current publication describes about development, optimization and validation of simultaneous estimation of impurities present in Sumatriptan and Naproxen sodium tablets using High-Performance Liquid Chromatography (HPLC). Perchlorate buffer (contains 1.0 mL/L of Perchloric acid and 4g/L of sodium perchlorate) is used as Elution phase~A along with acetonitrile as Elution phase~B.Step gradient mode elution technique is opted with a flow rate of 1.0 mL/min with ACE 5 C18 PFP 5µ,250 x 4.6mm column. All the probable impurities are well resolved at a satisfactory level, showing resolution more than 1.2 in sensitive robustness conditions for closely eluting peaks. The projected method is appropriate for quantification of SUM and NAP related known and unknown impurities that originate from the life cycle of the combination drug product. Selected quantification wavelength of 230 nm is found suitable for quantification purpose. Impurities show satisfactory responses and did not find any placebo interference at this working wavelength. Linearity data depicts a linear relationship with a coefficient of correlation greater than 0.99. The projected method is validated as per compendia recommendation as mentioned in ICH. The developed method is highly useful for quantification of impurities in Sumatriptan and Naproxen sodium tablets in a single method.

No abstract

A simple, sensitive, and reproducible ultra-performance liquid chromatography (UPLC) method for the determination of nine known potential impurities present in Olmesartan medoxomil and Hydrochlorothiazide tablets in fixed dose combination drug product was developed. Chromatographic separation was achieved between impurities at satisfactory level using Acquity UPLC HSS T3, 100 mm length  2.1 mm id with 1.8 µm particle size column. Gradient elution mode was kept using mobile phase A as 0.1% orthophosphoric acid buffer adjusted the pH 2.5 and acetonitrile as mobile phase B. Flow rate was kept at 0.5 mL min À1 with a monitoring wavelength of 225 nm. The method is fast and uses less consumption of solvents with shorter run time of 9 min. This can enable the separation of all known potential impurities of two active compounds in a rapid, precise, sensitive, cost, and time effective manner. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, solution stability, and robustness. The method is fast and is suitable for high-throughput analysis of the drug facilitating the processing of large-number batch samples.

No abstract

The present paper describes about precise, sensitive, rapid method for the determination of five potential impurities present in Azilsartan medoxomil Tablets. Separation of impurities at satisfactory level is achieved in Acquity UPLC BEH C 18 , 100 mm length x 2.1 mm id with 1.7 μm particle size column. Mobile phase A consists of 0.1% ortho phosphoric acid in water adjusted the pH to 3.0 with dilute sodium hydroxide and acetonitrile as Mobile phase B using gradient elution mode. Flow rate was kept at 0.5 mL.min -1 with a monitoring wavelength of 215 nm. Developed method was successfully validated as per method validation parameters recommended by International Conference on Harmonisation (ICH) for specificity, linearity, precision, accuracy, determination of LOD, LOQ, solution stability and robustness. The validated Reverse phase-Ultra Performance Liquid Chromatography (RP-UPLC) method was successfully used for quantitative determination of potential known and unknown impurities of Azilsartan medoxomil in Azilsartan medoxomil tablet dosage form, helping to identify the therapeutic efficacy at shorter run time.