scholarly journals Simultaneous Estimation of Racecadotril and Ofloxacin by Reverse Phase High Performance Liquid Chromatography Method in Pharmaceutical Dosage Forms.

2019 ◽  
Vol 9 (4-s) ◽  
pp. 165-170
Author(s):  
Komal Gupta ◽  
Deepika Sharma ◽  
Pooja Chawla

Background: Racecadotril and Ofloxacin (RACIGYL- O) drug combination are used for the treatment of diarrhea. The drugs have been estimated individually in formulations but no method has been developed for simultaneous estimation of these two drugs as combination. Objective: To develop and validate a high performance liquid chromatography method for the simultaneous estimation of Racecadotril and Ofloxacin in tablet dosage form. Method: A WATERS C18 column (250 x 4.6mm, 5 μm) with mobile phase consisting of acetonitrile, methanol and water 40:40:20v/v (pH adjusted to 2.7 of water with ortho phosphoric acid). The flow rate was 1.0mL/min and effluents were monitored at 210nm. Results: The retention time of RAC and OFL was 4.666 min and 2.551 min respectively. The developed method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision, robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ). Conclusion: The method show good reproducibility and recovery with %RSD less than 2. So the proposed method was found to be simple, rapid, precise and accurate and useful for the determination of RAC and OFL in bulk and pharmaceutical dosage forms.   Keywords: RP-HPLC, Racecadotril, Ofloxacin, ICH guidelines.

Author(s):  
Poornima K. ◽  
Channabasavaraj Kp.

<p><strong>Objective: </strong>A new, rapid, selective, precise, accurate and economical, isocratic, reverse phase high-performance liquid chromatography method has been developed for simultaneous estimation of loperamide hydrochloride and tinidazole in bulk and in tablet formulations.</p><p><strong>Methods: </strong>The separation was achieved by using Lithosphere RP C-18, (250 x 4.6 mm, 5 µm) end capped column with a mobile phase containing sodium-1-octane sulfonate buffer: methanol: acetonitrile (40:30:30%v/v/v) pH adjusted to 4.0 (using dilute orthophosphoric acid). The flow rate was 1.0 ml/m and column effluent was monitored at 224 nm. The method was validated as per international conference on chemical harmonization (ICH) guidelines.</p><p><strong>Results</strong>:<strong> </strong>Tinidazole and loperamide hydrochloride were eluted at about 3.1 and 5.4 min respectively, indicating the shorter analysis time. The proposed method was found to be accurate, precise and reproducible. The linearity was established in the concentration range of 10-50 µg/ml. Limit of detection (LOD) and Limit of quantification (LOQ) was found to be 0.001 µg/ml and 0.003 µg/ml for loperamide hydrochloride and 0.01 µg/ml and 0.03 µg/ml for tinidazole.</p><p><strong>Conclusion: </strong>This method can be used for routine analysis of formulations containing any of the above drugs or combinations without any alteration in the chromatographic conditions.</p>


Author(s):  
Mannem Durga Babu ◽  
Kesana Surendrababu

Objective: The objective of the study was to develop and validate a novel, specific, precise, and simple reversed-phase high-performance liquid chromatography method for the estimation of guaifenesin present in methocarbamol API and its pharmaceutical dosage forms. Methods: The baseline separation for methocarbamol and guaifenesin was achieved by utilizing a Inertsil ODS C18 (250 mm × 4.6 mm) 5 μm column particle size and an isocratic elution method. The mobile phase contains a mixture of water and acetonitrile in the ratio of 70:30 v/v, respectively. The flow rate of the mobile phase was 1.0 mL/min with a column temperature of 25°C and detection wavelength at 272 nm. The method was validated for a limit of detection (LOD), limit of quantification (LOQ), linearity, accuracy, and reproducibility with the help of the exhibit and simulated samples. Results: The LOD for guaifenesin was 0.62 μg/mL. The LOQ for guaifenesin was 1.87 μg/mL. The correlation coefficient obtained for impurity was >0.99. The recovery was obtained for impurity was 106.56% at 50%, 95.20% at 100%, and 100.45% at 150%. In tablet analysis, we can found 0.26% (<0.5%). Conclusion: The developed method was validated as per the ICH guidelines with respect to specificity, precision, linearity, accuracy, LOD and quantification, ruggedness, robustness, and solution stability.


Author(s):  
Liliya Logoyda ◽  
Yuliya Kondratova ◽  
Dmytro Korobko ◽  
Yuriy Soroka

Objective: The objective of this research was to develop more simple, sensitive, accurate, and less expensive analytical methods for the determination of captopril in medicines by Ultra-high-performance liquid chromatography.Materials and Methods: The chromatographic analysis of captopril performed on liquid chromatography Agilent 1290 Infinity II LC System.Results: A simple, rapid, sensitive, and specific method was developed for the determination of captopril by ultra-high-performance liquid chromatography in mono-medicines and pharmaceutical dosage forms in combination with hydrochlorothiazide without previous separation. Satisfactory resolution was achieved using Fused-Core® technology Ascentis Express C18 column (4.6×150 mm) and a mobile phase consisting of methanol and 0.1% solution of trifluoroacetic acid (40/60, v/v) at a flow rate 1.2 mL/minute and the wavelength detection was 220 nm. Ascentis Express columns, based on Fusеd-core pаrticle technоlogy, prоvide more than twice the speed and efficiency of traditiоnal cоlumns at half the backpressure of sub-2-μm columns. The retention time for captopril was 1.345 minute. The validation of this method was based on the ICH and USP guidelines.Conclusion: The results obtained in this research work clearly indicated that the assay was rapid, sensitive and successfully applied to the determination of both drugs in pharmaceutical dosage forms without interference from tablet excipients.


INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 35-40
Author(s):  
A. S. Bagde ◽  
V. V. Khanvilkar ◽  

The present work describes a validated reverse phase high performance liquid chromatography (RPHPLC) method for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate in pharmaceutical dosage from. The drugs were resolved using Hemochrom Intsil C18-5U column (250×4.6) mm in isocratic mode with mobile phase methanol: water (0.08% diethylamine, 0.02% of glacial acetic acid and pH 4.4 adjusted with orthophosphoric acid) in the ratio of 70:30 V/V at a flow rate of 1.0 mL/min. Retention time of dextromethorphan hydrobromide and quinidine sulphate were 4.9±0.2 and 3.6±0.2, respectively, at 292nm. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines. Linear responses were obtained in concentration ranges of 5-35 μg/mL for dextromethorphan hydrobromide and 4-16 μg/mL for quinidine sulphate, with correlation coefficient (r2) of 0.999 for both the drugs. A simple, selective, accurate, precise, robust and reliable RP-HPLC method thus developed and validated for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate.


2020 ◽  
Vol 10 (4) ◽  
pp. 79-86
Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde

A Simple, precise, and accurate stability-indicating reversed-phase high-performance liquid chromatography method has been established for the simultaneous estimation of rosuvastatin calcium and fenofibrate in combined bulk and tablet formulation. The chromatographic separation was performed on reverse phase Princeton (C18) (250 mm x 4.6 mm, 5µ) column with mobile phase as a mixture of water (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio (40:60) v/v at the flow rate 1.0 ml/min. Detection was carried out at wavelength 240 nm. The retention time under the optimized condition of Rosuvastatin calcium and Fenofibrate was found to be 2.485 & 3.905 minutes respectively. The calibration curve was linear in the range of 6-16 µg/ml and 87-232 µg/ml for rosuvastatin calcium and fenofibrate with a correlation coefficient of 0.9999 and 0.9994 respectively. Relative standard deviation values for all key parameters were less than 2.0%. The percentage recovery was found to be 99.66-100.37% and 99.13-100.44% for rosuvastatin calcium and fenofibrate respectively. The developed reversed-phase high-performance liquid chromatography method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical, and could be used for regular quality control of rosuvastatin calcium and fenofibrate in bulk and tablet formulations.  Keywords: Rosuvastatin calcium, Fenofibrate, RP-HPLC, Method validation, ICH guidelines.


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