Current Issue : October - December Volume : 2017 Issue Number : 4 Articles : 7 Articles
A rapid and sensitive stability indicating RP-HPLC method was developed for simultaneous estimation of empagliflozin and linagliptin in combined tablet formulations. Chromatography was carried out on a Thermo Scientific™ Hypersil ODS C18 HPLC Column (150 x 4.6 mm; 5 m particle size) by eluting with a mobile phase consisting of a 45:55 v/v mixture of 0.1 % orthophosphoric acid in water and acetonitrile (ACN) at a flow rate of 1.0 ml/ minute. The detection wavelength was set at 257 nm. Accuracy was assessed by using standard addition method. The developed HPLC method was validated with respect to precision, specificity, accuracy, linearity and robustness. Forced degradation studies on the formulation were conducted by adopting the proposed method to assess the stability of the analytes under acid, base, peroxide, thermal and photolytic conditions and suitability of the method to resolve the degradation products....
A new simple, sensitive and reproducible RP-HPLC method for the simultaneous estimation of hydrochlorothiazide and spiranolactone in pharmaceutical formulations was developed and validated. The separation was carried out on Phenomenex kinetex C18, 5μm (250×4.6 mm) column with acetonitrile: sodium dihydrogen and disodium hydrogen orthophasphate pH 6.4, 50:50% v/v as the mobile phase at the flow rate of 1.2 ml/min. The eluent detection was carried out using UV-Visible PDA detector at 254 nm. The retention time of hydrochlorothiazide and spiranolactone was 2.0 min and 5.7 min respectively. Linearity was observed hydrochlorothiazide and spiranolactone in the concentration range of 10-500 μg/ml and 10-5000 μg/ml respectively. The recovery of hydrochlorothiazide and spiranolactone was found to be 99.9.-100.2% and 100.2-100.8% respectively....
Sensitive and specific liquid-chromatography tandem mass spectrometry (UPLC-MS/MS) assay has been developed and validated\nfor simultaneous quantification of risperidone (RIS) and its active metabolite 9-hydroxyrisperidone (9-OH-RIS) in rat plasma using\nolanzapine (OLA) as internal standard (IS). Pharmacokinetics of risperidone and its active metabolite 9-hydroxyrisperidone was\ncompared across different doses (0.3, 1.0, and 6.0mg/kg). Serial blood sample was collected over a time of 48 hours and analyzed\nfor risperidone and its active metabolite 9-hydroxyrisperidone.The pharmacokinetics parameters including ...
An isocratic sensitive and precise reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and\nvalidated for the determination and quantification of hydrocortisone in controlled-release and conventional (tablets and injections)\npharmaceutical preparations. Chromatographic separation was achieved on an ODS (C18), 5 ...
A novel RP-HPLC method has been developed for the estimation of tramadol hydrochloride (TH) in the tablet dosage form using Phenomenox C18 column of dimensions 250 x 4.6 mm i.d., particle size 5 μm utilizing the system of buffer: acetonitrile (55:45 ratio) as the mobile phase at a flow rate of 1 ml/min, employing 271 nm detector, where the drug was eluted at 6.21 minutes. The newly developed method was suitably validated according to the ICH guidelines further for linearity, range, accuracy, precision and robustness. The proposed method was observed to be linear (r2 = 0.998) over the range concentration range of 12.5-75.0 μg/ml. The method was both accurate with the recovery of 99.5% and % RSD of less than 0.1% and extremely precise as indicated by the % RSD value of 0.1% in both the cases of intra- and inter-day studies. The method was also found to be much robust to deliver very accurate results, if the chromatographic conditions were altered. While the analysis, no interference from the diluents or excipients were encountered. The research will render a very simple, exceptionally cost-effective, extremely accurate, quite precise and highly reproducible method for the routine quality analysis of tramadol hydrochloride in tablets....
Background: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide.\nA combination of indacaterol maleate with glycopyrronium bromide has recently been approved as a once-daily\nmaintenance therapy in patients with COPD. The very low dose (Ã?¼g level/capsule) renders the analysis of such products\nchallenges. This study reports for the first time about HPLC method for the quality control of such combination\nand it is a stability indicating at the same time.\nResults: A rapid, simple, precise and reproducible HPLC method was developed and validated for simultaneous\ndetermination of indacaterol maleate and glycopyrronium bromide using tenoxicam as an internal standard. The\nchromatographic separation was achieved on an onyx monolithic C18 column (100 Ã?â?? 4.6 mm) using a mobile phase\nconsisting of acetonitrile and 30 mM phosphate buffer (pH 3.5) (30:70, v/v), run at a flow rate of 2 mL/min with UV\ndetection at 210 nm. The total analysis time was less than 3 min. The HPLC method was validated for linearity, limits of\ndetection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in\nthe concentration ranges of 1ââ?¬â??44 Ã?¼g/mL for indacaterol maleate and 0.5ââ?¬â??20 Ã?¼g/mL for glycopyrronium bromide. Stability\ntests were done through exposure of the analyte solution for different stress conditions and the results indicate\nno interference of degradants with HPLC method.\nConclusions: The method was successfully applied for the quantitative analysis of indacaterol maleate and glycopyrronium\nbromide both individually and in a combined pharmaceutical inhaler capsules to support the quality control\nand to assure the therapeutic efficacy of the two drugs. The simple procedure involved in sample preparation and the\nshort run-time added the important property of high throughput to the method....
A simple, accurate and precise stability indicating RP-HPLC method was developed for the simultaneous estimation of dexamethasone sodium phosphate (DSP) and gatifloxacin (GA) in ophthalmic formulation. Method was achieved in various degradation condition like acidic, basic, oxidative, thermal and photolytic. Maximum degradation was found to be in acidic condition for DSP 29% and for GA in thermal condition. In developed method ODS-BP Hyperchrome C18 (250×4.6 mm, 5 µm) column and 0.02M Phosphate buffer:Methanol (60:40 % v/v) (pH-3.5 adjusted using 1% Orthophosphoric acid) mobile phase was used. The retention time for DSP and GA was found to be 3.37 min and 5.70 min. respectively. Accuracy data was found to be within the limit. The precision (intra‐day, inter‐day and repeatability) of method was found within limits. The methods were validated according to ICH guidelines for evaluation of accuracy, LOD and LOQ, precision, repeatability, reproducibility etc. The proposed method was successfully applied to determination of these drugs in ophthalmic formulation....
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