Objectives: A selective, precise and accurate RP-HPLC stability indicating assay method has been developed for the simultaneous estimation of Azilsartan medoxomil and Cilnidipine in tablet dosage form. Materials and Methods: The efficient chromatographic separation of drug was achieved by using C 18 (150mm×4.6mm, Agilent 5µm) Column at ambient temperature. Mobile phase contains triethylamine buffer (pH 3.5 adjusted with ortho-phosphoric acid) and acetonitrile (40:60 V/V). Flow rate of mobile phase 1.0 ml/min using isocratic mode .Wavelength selected at 249 nm by using photo diode array detector. Results: The retention time of Azilsartan medoxomil peak 1, Azilsartan medoxomil peak 2 and Cilnidipine were noticed to be 2.16 min, 3.90 min and 9.52 min respectively. The linearity range for Azilsartan medoxomil and Cilnidipine were found to be 50 -150 µg/ml and 12.5-37.5 µg/ml and percent recoveries were noticed to be 99.27±0.58 and 98.65±0.49 respectively. Various stress testing conditions such applied to the drug ingredients and drug formulation. The degradants and drugs efficiently separated by using enhanced chromatographic conditions. The developed method was validated as per recommendation parameters of International council on harmonization guideline Q2(R1).
Conclusion:The validation parameters stated that the drug substances were efficiently separated from its degradants and developed method can be routinely applied for the simultaneous estimation of Azilsartan medoxomil and Cilnidipine in tablet formulation in a laboratory.
A novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18 column (5 μm particle size, 150 mm length × 4.6 mm diameter). The mobile phase was prepared by mixing 5 mM of phosphate buffer (pH 3.5) and methanol in a 75:25 v/v ratio delivered at a 1.0 mL/min flow rate. The eluents were monitored using a photodiode array detector at a wavelength of 322 nm. The stability-indicating nature of this method was evaluated by performing force degradation studies under various stress conditions, such as acidic, alkali, oxidative, thermal, and photolytic degradation. Significant degradation was observed during the alkali stress degradation condition. The degradation products generated during various stress conditions were well separated from the favipiravir peak. In addition, the major degradation product formed under alkali stress conditions was identified using UPLC-ESI-TQ-MS/MS and NMR. Method validation was performed according to the ICH Q2 (R1) guideline requirements. The developed method is simple, accurate, robust, and reliable for routine quality control analysis of favipiravir oral suspensions.
Objectives: A precise, accurate and selective stability-indicating reverse phase high performance liquid chromatographic assay method has been developed for the simultaneous quantitative determination of Tolperisone hydrochloride and Etoricoxib in tablets. Methods: The chromatographic separation of drugs was attained by using Eclipse plus C 18 (150 mm × 4.6 mm, Agilent 5µm) column at room temperature. The composition of mobile phase was mixture of 0.035M triethylamine (pH 3.0 adjusted with orthophosphoric acid) and acetonitrile in ratio of 70:30 v/v and flow rate of mobile phase 1.0 ml/min with isocratic elution. The signal of eluents was observed at 290 nm by using diode array detector. Results: The retention time of Tolperisone hydrochloride and Etoricoxib were found to be 2.826 min and 7.566 min, respectively. The linearity ranges for both drugs were found to be 5-15 μg/ml and the percent recoveries were found to be 99.39% and 99.15% for Tolperisone hydrochloride and Etoricoxib respectively. Various forced degradation conditions, such as alkali hydrolysis, acid hydrolysis, thermal degradation, photolytic degradation, and oxidative degradation, were applied to the drug ingredients and drug formulation. The degradants were efficiently separated from the drugs by using optimized chromatographic conditions. The developed method was validated as per recommendation parameters of International council on harmonization guidelines Q2(R1).
Conclusion:The validation parameters indicate that the drug substances were efficiently separated from its degradants and developed method can be routinely applied for the simultaneous quantitative determination of Tolperisone hydrochloride and Etoricoxib in combined tablet formulation in the quality control laboratory.
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