scholarly journals Development and Validation of a Simple RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Rosiglitazone in Pharmaceutical Dosage Forms

2013 ◽  
Vol 11 (2) ◽  
pp. 157-163
Author(s):  
Md Akteruzzaman ◽  
Asma Rahman ◽  
Md Zakir Sultan ◽  
Farhana Islam ◽  
Md Abdus Salam ◽  
...  
Keyword(s):  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

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)

scholarly journals Development and Validation of a Rapid RP-HPLC Method for the Determination of Venlafaxine Hydrochloride in Pharmaceutical Dosage forms using Experimental Design

2009 ◽  
Vol 6 (4) ◽  
pp. 1091-1102 ◽  
Author(s):  
Vanita Somasekhar ◽  
Dannana Gowrisankar ◽  
H. N. Shivakumar
Keyword(s):  
Mobile Phase ◽  
Optimization Technique ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Venlafaxine Hydrochloride

The objective of the current study was to develop a simple, accurate, precise and rapid reversed-phase HPLC method and subsequent validation as per ICH guidelines for the determination of venlafaxine hydrochloride in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a 5 μm Varian®Microsorb-MV 100 C18column (250 mmx4.6 mm) at ambient temperature. A 23factorial design consisting of 3 factors at 2 levels was set up to standardize the chromatographic conditions. A numerical optimization technique employing the desirability approach was used to locate the optimum chromatographic conditions. The optimum mobile phase consisted of acetonitrile, 0.04 M potassium dihydrogen phosphate buffer and methanol (45:25:30, v/v), with pH adjusted to 5.5 using 10% phosphoric acid solution. The mobile phase was delivered isocratically at a flow rate of 1 mL/min with UV detection at 224 nm. The calibration plots constructed using the optimized chromatographic conditions displayed good linear relationship in the concentration range of 1-50 μg/mL with r=0.9992. The method was validated for precision, accuracy, robustness and recovery. The minimum detectable and minimum quantifiable amounts were found to be 0.568 and 1.72 μg/mL, respectively and the method was found to be reproducible from the statistical data generated. Venlafaxine hydrochloride was eluted at 3.43 min

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 ◽  
...  
Keyword(s):  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
Pharmaceutical Journal ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Allowable Limit ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

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

A NEW BIOANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE MONOHYDRATE IN HUMAN PLASMA BY USING RP-HPLC

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (12) ◽  
pp. 18-25
Author(s):  
S. A Kumar ◽  
◽  
M Debnath ◽  
J. V. L. N. S Rao ◽  
G Sankar
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Precipitation Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Rp Hplc

A new RP-HPLC method for the quantitative determination of metformin and sitagliptin in human plasma was developed and validated as per US-FDA guidelines. The drug was spiked in the plasma and extracted with mobile phase by precipitation method. The extracted analyte was injected into Symmetry C18 (4.6 x 150 mm, 3.5μm, Make: XTerra) or equivalent, maintained at ambient temperature and effluent was monitored at 254 nm. The mobile phase consisting of potassium dihydrogen phosphate [pH 5.8]: acetonitrile [HPLC Grade] (65:35 v/v). The flow rate was maintained at 0.9 mL/min. The calibration curve for metformin and sitagliptin was linear from 10.0 to 35.0 µg/mL (r2= 0.999) and 1.0 to 3.5 µg/mL (r2= 0.998) respectively. The inter-day and intra-day precision was found to be within limits. The lower limit of quantification (LLOQ) for metformin and sitagliptin were found to be 0.026 and 0.70 μg/mL respectively. The average % recovery for metformin and sitagliptin were found to be 98.82-100.03 & 99.76-100.89 % respectively and reproducibility was found to be satisfactory. This RP-HPLC method is suiTable for determining the concentration of metformin and sitagliptin in human plasma and it can applied for routine analysis for determination of the metformin and sitagliptin from dosage form during pharmacokinetic study.

scholarly journals Optimization and Validation of an RP-HPLC Method for Direct Determination of Metformin Hydrochloride in Human Urine and in a Dosage Form

2010 ◽  
Vol 93 (6) ◽  
pp. 1821-1828 ◽  
Author(s):  
Alaa El-Gindy ◽  
Mohammed Wafaa Nassar ◽  
Nasr Mohammed El-Abasawy ◽  
Khalid Abdel-Salam Attia ◽  
Maisra Al-Shabrawi
Keyword(s):  
Human Urine ◽  
Direct Determination ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Linear Calibration ◽  
Rp Hplc ◽  
Acid Sodium Salt

Abstract A simple, selective, sensitive, accurate, and precise method was developed for determination of metformin hydrochloride (MF) in human urine using RP-HPLC. The method depends upon using an octylsilyl (C8) 5 m particle size column at ambient temperature with mobile phase consisting of 33 mM sodium dihydrogen phosphate containing 6.38 mM hexanesulfonic acid sodium salt and adjusted to apparent pH 3.0 with phosphoric acidacetonitrile (93 7, v/v) at a flow rate of 1.5 mL/min. Quantitation was achieved with UV detection at 231 nm based on peak area with a linear calibration curve over the concentration range of 0.0150 g/mL. The proposed method was applied to the determination of the urinary excretion pattern of MF (the cumulative amounts excreted were calculated without pretreatment of the urine sample) and for determination of the dissolution pattern of MF tablets. The proposed method was completely validated according to the U.S. Food and Drug Administration guidelines.

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR THE SIMULTANEOUS ESTIMATION OF ESCITALOPRAM AND ETIZOLAM IN BULK AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (02) ◽  
pp. 50-56
Author(s):  
S. Vadrevu ◽  
◽  
K. Govindarao
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Good Resolution ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Mobile Phases

The developed RP-HPLC method allows rapid and precise determinations of escitalopram and etizolam in bulk and pharmaceutical dosage forms. The objective of the proposed method was to develop a simple and accurate method for the determination of escitalopram and etizolam by RP-HPLC method in pharmaceutical dosage forms & its stability indicative studies. A series of mobile phases were tried; among the various mobile phases , potassium dihydrogen phosphate buffer and dipotassium hydrogen phosphate 0.02 M, pH 3.0 : acetonitrile (20:80) is an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at less than 2 mL/min. The linearity and correlation coefficient of escitalopram and etizolam at 0-45μg/mL and 0-75μg/mL was found to be 0.998 & 0.998, respectively. The LOD was found to be 0.1 mg/mL and 0.3 mg/mL and LOQ was found to be 0.15 mg/mL and 0.45 mg/mL for escitalopram and etizolam, respectively, which represents that sensitivity of the method is high. The method was known to be accurate with the assay method. The % assay was found to be 100 % and 98%. The developed method showed a good accuracy and precision. The % RSD is for escitalopram and etizolam was found to be 1.50 and 1.22. This method shows good reproducibility of the results. Furthermore, this method was simple, sensitive, and accurate. Hence, the chromatographic method developed for escitalopram & eizolam can be effectively applied for routine analysis.

scholarly journals Validated RP-HPLC and TLC methods for simultaneous estimation of tamsulosin hydrochloride and finasteride in combined dosage forms

2010 ◽  
Vol 60 (2) ◽  
pp. 197-205 ◽  
Author(s):  
Dipti Patel ◽  
Natubhai Patel
Keyword(s):  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Photodiode Array ◽  
Bulk Drug ◽  
Layer Chromatography

Validated RP-HPLC and TLC methods for simultaneous estimation of tamsulosin hydrochloride and finasteride in combined dosage formsReversed-phase high-performance liquid chromatography (RP-HPLC) and thin-layer chromatography (TLC) methods have been developed and validated for simultaneous estimation of tamsulosin hydrochloride and finasteride in bulk drug and in combined dosage forms. RP-HPLC separation was achieved on a Phenomenex C18column using methanol/0.02 mol L-1ammonium acetate buffer/triethylamine (79.9 + 20 + 0.1,V/V/V) (pH 9.2) as mobile phase. TLC separation was achieved on an aluminium-backed layer of silica gel 60 F254using toluene/methanol/triethylamine (9 + 1.5 + 1,V/V/V) as eluent. Quantification was achieved with photodiode array (PDA) detection at 235 nm over the concentration range 0.5-16 and 1-50 μg mL-1with mean recovery of 99.8 ± 0.9 and 100.0 ± 0.8% for tamsulosin hydrochloride and finasteride, respectively, by the RP-HPLC method. Quantification was achieved with UV detection at 270 nm over the concentration range 100-2000 ng per spot and 250-5000 ng per spot with mean recovery of 98.9 ± 0.9 and 99.6 ± 0.7 % for tamsulosin hydrochloride and finasteride, respectively, by the TLC method. Both methods are simple, precise, accurate and sensitive and are applicable to the simultaneous determination of tamsulosin hydrochloride and finasteride in bulk drug and in combined dosage forms.

scholarly journals A new validated RP-HPLC method for the determination of Tinidazole and Roxithromycin in its bulk and pharmaceutical dosage forms

2020 ◽  
Author(s):  
N. M. D. Akram ◽  
N. Madana Gopal ◽  
A. Balakrishna ◽  
N. Bakthavatchala Reddy ◽  
Grigory V. Zyryanov
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

scholarly journals RP-HPLC Determination of Raloxifene in Pharmaceuticl Tablets

2006 ◽  
Vol 3 (1) ◽  
pp. 60-64 ◽  
Author(s):  
P. Venkata Reddy ◽  
B. Sudha Rani ◽  
G. Srinu Babu ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

A reverse phase HPLC method is developed for the determination of Raloxifene in pharmaceutical dosage forms. Chromatography was carried out on an inertsil C18 column using a mixture of acetonitrile and phosphate buffer (30:70 v/v) as the mobile phase at a flow rate of 1 mL/min. Detection was carried out at 290 nm .The retention time of the drug was 10.609 min. The method produced linear responses in the concentration range of 0.5-200 µg/mL of Raloxifene. The method was found to be applicable for determination of the drug in tablets.

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