scholarly journals A Validated RP-HPLC Method for Simultaneous Estimation of Antidiabetic Drugs Pioglitazone HCl and Glimepiride

2013 ◽  
Vol 16 (1) ◽  
pp. 69-75 ◽  
Author(s):  
Khohinur Hossain ◽  
Asma Rahman ◽  
Md Zakir Sultan ◽  
Farhana Islam ◽  
Md Akteruzzaman ◽  
...  

A simple, fast and economic reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous and quantitative analyses of pioglitazone HCl and glimepiride in pharmaceutical dosage forms. The method was developed using the mobile phase comprising of potassium dihydrogen phosphate buffer (KH2PO4) at pH 3.4 and acetonitrile in the ratio of 40:60 (v/v) over C-18 bonded silica column (250 x 4.6 mm, 5 um, Phenomenex Inc.) at ambient temperature. The flow rate was at 0.8 min/min and the eluent was monitored by UV detection at 235 nm. The recoveries were found to be >97% for pioglitazone and >99% for glimepiride, demonstrative of accuracy of the protocol. Inter-day and intra-day precision of the new method were less than the maximum allowable limit (RSD% ? 2.0) according to ICH, USP and FDA guidelines. The method showed linear response with correlation coefficient (r2) values of 0.9991 for pioglitazone and 0.9999 for glimepiride. Therefore, the method was found to be accurate, reproducible, sensitive and less time consuming and can be successfully applied for the assay of pioglitazone and glimepiride in combined formulations. DOI: http://dx.doi.org/10.3329/bpj.v16i1.14497 Bangladesh Pharmaceutical Journal 16(1): 69-75, 2013

2015 ◽  
Vol 16 (2) ◽  
pp. 137-141 ◽  
Author(s):  
Saleha Tanjin ◽  
Farhana Islam ◽  
Md Zakir Sultan ◽  
Asma Rahman ◽  
Sharmin Reza Chowdhury ◽  
...  

A simple, sensitive and precise reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the estimation of naproxen in pharmaceutical dosage forms. The method was developed using the mobile phase comprising of dibasic sodium phosphate buffer (Na2HPO4) at pH 7.80 (adjusted by sodium hydroxide) and acetonitrile in the ratio of 70:30 (v/v) over C-18 column (250 x 4.6 mm, 5?m, Phenomenex Inc.) at ambient temperature. The flow rate was at 0.7 ml/min and the column washing was monitored by UV detector at 225 nm. The retention time of naproxen was 4.8 ± 0.1 min. The recovery was found to be >97% which is demonstrative of accuracy of the protocol. Inter-day and intra-day precision of the newly developed method were less than the maximum allowable limit (RSD% ? 2.0) according to ICH, USP and FDA guidelines. The method showed linear response with correlation coefficient (r2) value of 0.9991. Therefore, the method was found to be accurate, reproducible, sensitive and less time consuming and can be successfully applied for routine analysis of naproxen in pharmaceutical formulations. DOI: http://dx.doi.org/10.3329/bpj.v16i2.22295 Bangladesh Pharmaceutical Journal 16(2): 137-141, 2013


2019 ◽  
Vol 11 (1) ◽  
pp. 94
Author(s):  
Swati Sahani ◽  
Vandana Jain

Objective: The objective of this study was to develop and validate a novel, simple, rapid, precise and accurate reversed-phase high performance liquid chromatographic (RP-HPLC) method for simultaneous quantitative estimation of berberine, quercetin, and piperine in Ayurvedic formulation.Methods: The chromatographic separation was achieved using a stationary phase C18 shim-pack (150 mm x 4.6 mm, 5µ) column and mobile phase consisted of acetonitrile: 0.04 M potassium dihydrogen phosphate buffer (pH 3.0 adjusted using orthophosphoric acid) in a ratio of 65:35 v/v, with a flow rate of 1 ml/min and UV detection at 255 nm.Results: The retention time of berberine, quercetin, and piperine were found to be 2.7, 3.0 and 6.3 min respectively. Linearity for berberine, quercetin, and piperine were found in the range of 12-28 µg/ml. All calibration curve showed good linear correlation coefficients (r2˃ 0.999) within the tested ranges. Mean percent recoveries for berberine, quercetin, and piperine were found to be within the acceptance limits (98-120%). The percent relative standard deviation (% RSD) for precision was found to be less than 2% which indicates method is precise.Conclusion: The developed method is novel, simple, precise, accurate and can be used for quantitative analysis and quality control of the raw material as well as other commercial formulations containing these three markers.


Author(s):  
CELINA NAZARETH ◽  
GISELLE FIZARDO ◽  
CHARMAINE VAZ

Objective: This study describes a new, simple, precise, accurate, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) cleaning validation method for simultaneous estimation of rosuvastatin and aspirin. Methods: The proposed RP-HPLC method was carried out on AGILENT-ZORBAX RP-Inertsil column (250 mm × 4.6 mm, 5 μm) in an isocratic mode utilizing potassium dihydrogen phosphate buffer (pH 2.5 with OPA):acetonitrile (50:50,v/v) as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 243 nm using UV detector. Results: The method was found specific as there was no swab interference. The Beer–Lambert’s law was obeyed in the concentration range of 0.5–20 μg/ml for both rosuvastatin and aspirin. The mean percentage recoveries at 100% level were 89.4% for rosuvastatin and 82.1% for aspirin. The limit of detection and limit of quantification for rosuvastatin and aspirin were 0.03 μg/ml and 0.1 μg/ml, respectively. The method was found to be robust and precise with percentage RSD <2.0%. Conclusion: A simple, novel, and economical RP-HPLC method for cleaning validation has been developed for the simultaneous estimation of rosuvastatin and aspirin. The method was validated as per ICH guidelines for specificity, linearity, accuracy, precision, and robustness. The developed method can be used as a sensitive analytical tool for ensuring the effectiveness of the cleaning procedure adopted.


2013 ◽  
Vol 11 (2) ◽  
pp. 157-163
Author(s):  
Md Akteruzzaman ◽  
Asma Rahman ◽  
Md Zakir Sultan ◽  
Farhana Islam ◽  
Md Abdus Salam ◽  
...  

The objective of this study was to develop a simple, efficient, precise and accurate reversed phase HPLC (RP-HPLC) method for simultaneous determination of metformin in combination with rosiglitazone in newly formulated tablets. The combination of these drugs are commonly used and prescribed as anti-diabetic drugs in Bangladesh. The method has been developed by using the mobile phase comprising of sodium dihydrogen phosphate (NaH2PO4) buffer (pH 3.5) and acetonitrile (60:40, v/v) at a flow rate of 0.7 ml/min over C18 bonded silica column (ODS) (250 x 4.6 mm, 5 ?) at ambient temperature. The effluents were monitored at 230 nm and retention times were found to be 3.35 min and 11.95 min for metformin and rosiglitazone, respectively. Calibration curves were determined with a range from 0.03125 to 0.50 ?mole/ml of standards and the regression coefficients (r2) were found as 0.999 for metformin and 1.0 for rosiglitazone. The assay was validated for the accuracy, precision etc. according to ICH, USP and FDA guidelines. The proposed method can be useful in routine analysis for quantitative determination of metformin hydrochloride and rosiglitazone in pharmaceutical dosage forms. DOI: http://dx.doi.org/10.3329/dujps.v11i2.14574 Dhaka Univ. J. Pharm. Sci. 11(2): 157-163, 2012 (December)


2014 ◽  
Vol 20 (1) ◽  
pp. 39-47 ◽  
Author(s):  
Shweta Havele ◽  
Sunil Dhaneshwar

A simple, precise and accurate high performance liquid chromatography (HPLC) method was developed for the simultaneous estimation of metformin hydrochloride, rosiglitazone maleate, glibenclamide present in multicomponent dosage forms. Chromatography was performed on a 25 cm ? 4.6 mm i.d., 5-?m particle, C18 column with 78:22 (v/v) methanol: 20 mM potassium dihydrogen phosphate buffer as mobile phase at a flow rate of 1.0 ml/min and UV detection at 238 nm for metformin hydrochloride, rosiglitazone maleate, and glibenclamide. The total elution time was shorter than 9 min. This method was found to be precise and reproducible. This proposed method was successfully applied for the analysis of metformin hydrochloride, rosiglitazone maleate, glibenclamide as a bulk drug and in pharmaceutical formulation without any interference from the excipients.


2012 ◽  
Vol 9 (3) ◽  
pp. 1223-1229 ◽  
Author(s):  
S. D. Bhinge ◽  
S. M. Malipatil ◽  
A. Jondhale ◽  
R. Hirave ◽  
A. S. Savali

The present manuscript describes the development and validation of an isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Atorvastatin calcium and Fenofibrate in raw material and tablet. Atorvastatin Calcium, Fenofibrate and Diclofenac (internal standard) were well separated using a reversed phase column and mobile phase consisting of acetonitrile:KH2PO4(50 mM) (72:28v/v) (pH 4.1). The mobile phase was pumped at 1.0 mL/min flow rate and atorvastatin calcium and fenofibrate were detected by UV-Vis detection at 260 nm. The retention time for atorvastatin calcium, Internal Standard and fenofibrate were 4.34, 5.35 and 12.05 min, respectively. The LOD and LOQ was found to be 1.95 and 4.80 µg/mL for atorvastatin calcium whereas for fenofibrate it was found to be 1.73 and 3.98 µg/mL in mobile phase. The developed method was validated by applying parameters as precision, accuracy, selectivity, reproducibility and system suitability tests.


2013 ◽  
Vol 8 ◽  
pp. ACI.S11256 ◽  
Author(s):  
Sylvain Auvity ◽  
Fouad Chiadmi ◽  
Salvatore Cisternino ◽  
Jean-Eudes Fontan ◽  
Joël Schlatter

A stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of betaxolol hydrochloride, a drug used in the treatment of hypertension and glaucoma. The desired chromatographic separation was achieved on a Nucleosil C18, 4 μm (150 × 4.6 mm) column, using isocratic elution at a 220 nm detector wavelength. The optimized mobile phase consisted of a 0.02 M potassium dihydrogen phosphate: methanol (40:60, v/v, pH 3.0 adjusted with o-phosphoric acid) as solvent. The flow rate was 1.6 mL/min and the retention time of betaxolol hydrochloride was 1.72 min. The linearity for betaxolol hydrochloride was in the range of 25 to 200 μg/mL. Recovery for betaxolol hydrochloride was calculated as 100.01%-101.35%. The stability-indicating capability was established by forced degradation experiments and the separation of unknown degradation products. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method was applied for the estimation of betaxolol hydrochloride in commercially available tablets.


Author(s):  
Krutika Patel ◽  
Sudheer Kumar Verriboina ◽  
S.G. Vasantharaju

A simple, accurate, specific and stability-indicating RP-HPLC method was developed for simultaneous determination of chlorzoxazone, diclofenac sodium and paracetamol, using C18 Vydac Monomeric 120A (250 × 4.6mm, 5μ) at 40ºC. The mobile phase contains a mixture of 20mM potassium dihydrogen phosphate buffer (pH 6.2 adjusted with potassium hydroxide) and acetonitrile (30:70 v/v). The flow rate was 1ml/min and detection was carried out at 275nm using PDA detector. The retention time of paracetamol, chlorzoxazone and diclofenac sodium were 3.28mins, 13.27mins and 15.61mins respectively. The analytical curve was linear over a concentration range of 0.65- 6.5μg/ml for paracetamol, 1-10μg/ml for chlorzoxazone and 0.1-1μg/ml for diclofenac sodium. The drugs in bulk and tablet were subjected to acid and alkali hydrolysis, oxidation, thermal and photolytic degradation. This method can be successfully employed for simultaneous quantitative analysis of Chlorzoxazone, Diclofenac sodium and Paracetamol in bulk drug and tablet formulation.


2012 ◽  
Vol 1 (12) ◽  
pp. 410-413 ◽  
Author(s):  
Sukhbir Lal Khokra ◽  
Balram Choudhary ◽  
Heena Mehta

A rapid, simple and highly sensitive reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitative determination of Rabeprazole sodium and Aceclofenac in a combined dosage form. Rabeprazole sodium and Aceclofenac were chromatographed using C-18 column as stationary phase and methanol: acetonitrile: water (60 : 10 : 30 v/v/v) as the mobile phase at a flow rate of 1.0 ml/min at ambient temperature and detected at 280 nm. The retention time (RT) of Rabeprazole sodium and Aceclofenac were found to be 5.611 min and 2.102 minute, respectively. The linearities of Rabeprazole sodium and Aceclofenac were in the range of 1-10 µg/ml and 3-15 µg/ml, respectively. The limit of detection was found to be 0.091 µg/ml for Rabeprazole sodium and 0.043 µg/ml for Aceclofenac. The proposed method was applied for the determination of Rabeprazole sodium and Aceclofenac in a combined dosage form and result was found satisfactory.DOI: http://dx.doi.org/10.3329/icpj.v1i12.12450 International Current Pharmaceutical Journal 2012, 1(12): 410-413


1970 ◽  
Vol 3 (1) ◽  
pp. 49-53 ◽  
Author(s):  
Gaurav Patel ◽  
Sanjay Patel ◽  
Dhamesh Prajapiti ◽  
Rajendra Mehta

A reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in combine dosage form. Amlodipine Besylate (AML) is a long acting calcium channel blocker and in the treatment of CVS disorder. Hydrochlorothiazide (HCT) is a diuretic and antihypertensive. The mobile phase used was a combination of Water: Methanol (70:30). The detection of the combined dosage form was carried out at 245nm and a flow rate employd was 0.5ml/min. The retention time for Amlodipine Besylate and Hydrochlorothiazide was found to be 6.95 and 2.65 min respectively. Linearity was obtained in the concentration range of 6 to 18μg/ml of Amlodipine Besylate and 6 to 18μg/ml of Hydrochlorothiazide with a correlation coefficient of 0.997 and 0.9974. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (5 μm size, 250mm, 4.6mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method is precise, selective and rapid for simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in routine analysis. Key Words: Simultaneous Estimation; Amlodipine Besylate; Hydrochlorothiazide; HPLC. DOI: 10.3329/sjps.v3i1.6798S. J. Pharm. Sci. 3(1): 49-53


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