scholarly journals Ion-pairing reverse-phase high performance liquid chromatography method for simultaneous estimation of atenolol and indapamide in bulk and combined dosage form

2012 ◽  
Vol 74 (3) ◽  
pp. 271 ◽  
Author(s):  
KG Baheti ◽  
N Shah ◽  
S Shaikh
Author(s):  
Ramreddy Godela ◽  
Sherisha Bhavani

Objective: The most important objective of the present research work is to develop simple, specific, rapid, accurate, and sensitive reverse-phase high-performance liquid chromatography method and validated for the qualitative and quantitative determination of valsartan in its active pharmaceutical ingredient and tablet dosage form according to ICH guidelines.Proposed Method: An isocratic separation was done using Phenomenex C18 column possess 75×4.6 mm, 2.6 μ,100 A0 dimensions with mobile phase composition of water:acetonitrile (30:70% v/v) by maintaining 1 ml/minute flow rate and response detected at a wavelength of 247 nm.Results: The retention time of valsartan was found to be 2.71 minutes, limit of detection and limit of quantification were observed at 1.24 μg/ml and 3.6 μg/ml concentration, respectively, and a calibration curve was linear in the concentration range of 5-50 μg/ml with coefficient of correlation 0.99. The percentage recovery (accuracy) was in the range of 98.9-102%, and the % relative standard deviation was observed to be <2%.Conclusion: The proposed method was validated for accuracy, precision, sensitivity, linearity, and robustness and successfully employed for the quantitative determination of valsartan in tablet dosage form in quality control department of pharmaceutical industry.


Author(s):  
RASHMI PATIL ◽  
UTTARA JAISWAR ◽  
VANDANA JAIN

Objective: The study aims to develop and validate a novel reverse-phase high-performance liquid chromatographic method for simultaneous estimation of andrographolide and aloe-emodin in herbal formulation and validate as per the International Conference on Harmonization (ICH) guidelines. Methods: The analysis was carried on a Shimadzu LC Prominence-i 2030 model with the Lab Solution software. The column used for separation was Prontosil C18 (250×4.6 mm, 5 μ), with a mobile phase consisting of acetonitrile and 0.05% orthophosphoric acid (45:55), at a flow rate of 1 ml/min, column temperature was maintained at 28°C and effluents were monitored at 225 nm. The injection volume was 10 μl. Results: The retention time of andrographolide and aloe-emodin was found to be 4.57±0.2 min and 12.29±0.2 min, respectively. The markers were resolved using linear responses that were obtained in concentration ranges of 0.5–60 μg/ml with correlation coefficient (r2) of 0.9992 and 0.999 for andrographolide and aloe-emodin, respectively. The precision results were found to be satisfactory, which indicates that the method is precise. The recovery values lie in the range of 98–120% indicating the accuracy of the method. Conclusion: A novel, simple, accurate, precise, and robust reverse-phase high-performance liquid chromatography method was developed for the simultaneous estimation of andrographolide and aloe-emodin. The developed method can be used for analysis of the formulations containing these phytoconstituents.


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>


2013 ◽  
Vol 2013 ◽  
pp. 1-7
Author(s):  
Neha Singhal ◽  
Kalpesh Gaur ◽  
Anoop Singh ◽  
Karni Singh Sekhawat

The present study described a new, simple, accurate, and precise high performance liquid chromatography method for the simultaneous determination of Ambroxol and Doxofylline in combined tablet dosage form. The chromatographic method was standardized using a BDS hypersil C18, 250 mm × 4.6 mm, 5 μ (particle size), Thermo scientific from Germany with isocratic conditions, and mobile phase containing potassium dihydrogen orthophosphate buffer-pH 4.5 (0.05 M KH2PO4): acetonitrile (60 : 40) at flow rate of 1 ml/min using UV detection at 254 nm. The retention times of Ambroxol and Doxofylline were 3.510 min and 7.247 min, respectively. The method was linear over the concentration range for Ambroxol 3.75–11.25 μg/mL and for Doxofylline 50-150 μg/mL. The recovery of Ambroxol and Doxofylline was found to be in the range of 99.42–101.18% and 99.37–100.28%, respectively. The validation of method was carried out using ICH guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.


Author(s):  
MEGHA PATEL ◽  
PARESH PATEL ◽  
DHARA PATEL

Objective: A simple, rapid, accurate, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of olanzapine (OLZ) and aripiprazole (APR) in synthetic mixtures. Methods: The stationary phase used for chromatographic separation was Phenomenex C18 column (250 mm × 4.6 mm i.d, particle size 5 μm) and mobile phase used for separation was methanol: Phosphate buffer (pH 3) taken in ratio of 75:25 %v/v. The flow rate was used 1.0 ml/min at room temperature and drugs detected at 240 nm with injection volume 20 μL. Results: The retention time for OLZ and APR was found to be 4.231 and 6.523 min, respectively. The linearity was performed using a concentration range of 0.5–3.0 for both drugs. The correlation coefficient was found to be 0.999 for OLZ and APR. The % purity of both the drug was found to be 98–102%. The proposed RP-HPLC method has been validated, according to International council on harmonization Q2 (B) guidelines. Conclusion: There was no interference of any diluents and excipients in the determination of drugs from synthetic mixture. Hence, the developed method can be used for routine quality control analysis.


Author(s):  
Anjoo Kamboj ◽  
Manisha Bhatti ◽  
Pooja Atri

ABSTRACTObjective: Xanthium strumarium is a cocklebur or burweed belonging to family Asteraceae and commonly found as a weed, is widely distributed inNorth America, Brazil, China, Malasia, and hotter part of India. The herb is traditionally used mostly in treating several ailments. The present studydeals with development and validation of a reliable reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneousestimation of Stigmasterol and β-sitosterol in the various extracts of the plant.Methods: The proposed method utilizes a Qualisil Gold C18 column (250×4.6 mm), 5 µm particle size, under isocratic elution conditions with themixture of acetonitrile:ethanol:water (85:14:1 v/v/v) at 25° as a mobile phase. An effluent flow rate of 1 ml/minute and ultraviolet detection at202 nm was used for the analysis of Stigmasterol and β-sitosterol.Results: The described method was linear in the range of range of 100-500 µg/ml and 10-500 µg/ml for stigmasterol and β-sitosterol respectively,with excellent correlation coefficients. The precision, robustness, and ruggedness values were also within the prescribed limits (<2%). The recoveryvalues were within the range, which indicates that the accuracy of the analysis was good and that the interference of the matrix with the recovery ofphytosterols was low. The phytosterols were found to be stable in a stock solution for 24 hrs (percentage relative standard deviation was below 2%)and no interfering extra peaks were observed under controlled stress conditions.Conclusion: The proposed method is simple, specific, precise, accurate, and reproducible and thus can be used as appropriate method for routineanalysis of X. strumarium phytosterols in quality control laboratories.Keywords: Xanthium strumarium, Reverse phase high-performance liquid chromatography method, Precision, Phytosterols, Quality control.


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