scholarly journals Simultaneous Determination of Paracetamol, Acetyl Salicylic Acid, Mefenamic Acid and Cetirizine Dihydrochloride in the Pharmaceutical Dosage Form

2010 ◽  
Vol 7 (s1) ◽  
pp. S495-S503 ◽  
Author(s):  
Freddy H. Havaldar ◽  
Dharmendra L. Vairal
Keyword(s):  
Salicylic Acid ◽  
Mefenamic Acid ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Reversed Phase ◽  
Hplc Method ◽  
Acetyl Salicylic Acid ◽  
Pharmaceutical Dosage Form ◽  
Constant Flow Rate

A simple, specific, accurate and economical isocratic reversed phase liquid chromatographic (RP-HPLC) method was developed and subsequently validated for the determination of paracetamol, acetyl salicylic acid, mefenamic acid and cetirizine dihydrochloride. Separation was achieved with a Nucleodur 100 C–18 column having 250 × 4.6 mm i.d. with 5 µm particle size and disodium hydrogen phosphate buffer adjusted to pH 6.5 using diluted orthophosphoric acid and acetonitrile (60:40 v∕v) as eluent at a constant flow rate of 1.0 mL per min. UV detection was performed at 220 nm. The retention time of acetyl salicylic acid, paracetamol, mefenamic acid and cetirizine dihydrochloride were 2.01 min, 2.92 min, 4.91 min and 10.2 min respectively. This method is simple, rapid and selective and can be used for routine analysis of analgesic and antipyretic drugs in pharmaceutical formulations. The proposed method was validated and successfully used for estimation of paracetamol, acetyl salicylic acid, mefenamic acid and cetirizine dihydrochloride in the pharmaceutical dosage form.

scholarly journals Simultaneous Estimation of Glimepiride, Rosiglitazone and Pioglitazone Hydrochloride in the Pharmaceutical Dosage Form

2010 ◽  
Vol 7 (4) ◽  
pp. 1326-1333 ◽  
Author(s):  
Freddy H. Havaldar ◽  
Dharmendra L. Vairal
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Preparation ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Constant Flow Rate ◽  
Phase Liquid ◽  
Liquid Chromatographic

A simple, specific, accurate and economical gradient reversed phase liquid chromatographic (RP-HPLC) method was developed and subsequently validated for the determination of glimipiride, rosiglitazone and pioglitazone hydrochloride. Separation was achieved with a nucleodur C–18 column having 250×4.6 mm i.d. with 5 µm particle size and water HPLC grade adjusted to pH 3.0 using diluted orthophosphoric acid and acetonitrile (80:20 v∕v) with gradient program as eluent at a constant flow rate of 0.8 ml per min. UV detection was performed at 215 nm. The retention time of glimipiride, rosiglitazone and pioglitazone hydrochloride were about 17.9 min, 6.31 min and 8.24 min respectively. This method is simple, rapid and selective and can be used for routine analysis of antidiabetic drugs in pharmaceutical preparation. The proposed method was validated and successfully used for estimation of glimipiride, rosiglitazone and pioglitazone hydrochloride in the pharmaceutical dosage form.

scholarly journals Stability Indicating HPLC Method for the Determination of Delamanid in Pharmaceutical Dosage Form

2021 ◽  
Vol 11 (1-s) ◽  
pp. 108-112
Author(s):  
Advaita B. Patel ◽  
Deepa R. Patel ◽  
Dhaval M. Patel ◽  
Mansi Babaria
Keyword(s):  
Analytical Method ◽  
Mobile Phase ◽  
Dosage Form ◽  
Degradation Products ◽  
Stress Test ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating

Delamanid is successfully used for treatment of MDR TB. A stability indicating analytical method has been developed and validated. In this study Delamanid was degraded under different stress test conditions as per International Conference on Harmonization. The degraded samples were used to develop a stability-indicating high performance liquid chromatographic (HPLC) method for the Delamanid. The Delamanid was well separated from degradation products using a reversed-phase Hypersil BDS C18 (250 mm × 4.6mm i.d., 5µm) column and a mobile phase comprising of 0.01M pH 2.70 Phosphate Buffer: Acetonitrile (pH 3.50) 70:30, pH of mobile phase was adjusted with Glacial acetic acid and other HPLC parameters were flow rate 1 mL/min, detection wavelength 254 nm and injection volume 10 µl. The method was validated for linearity, precision, accuracy, ruggedness and robustness. Results obtained after validation study indicating that the proposed single method allowed analysis of Delamanid in the presence of their degradation products formed under a variety of stress conditions. The developed procedure was also applicable to the determination of stability of the Delamanid in commercial pharmaceutical dosage form. Keywords:  Delamanid, stability indicating analytical method, HPLC

Simultaneous Determination of Ursodeoxycholic Acid and Chenodeoxycholic Acid in Pharmaceutical Dosage Form by HPLC–UV Detection

2017 ◽  
Vol 100 (1) ◽  
pp. 59-64 ◽  
Author(s):  
Mostafa A Khairy ◽  
Fotouh R Mansour
Keyword(s):  
Ursodeoxycholic Acid ◽  
Simultaneous Determination ◽  
Chenodeoxycholic Acid ◽  
Dosage Form ◽  
Reference Method ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detection ◽  
Pharmaceutical Dosage Form

Abstract A reversed-phase HPLC method was developed for the simultaneous determination of ursodeoxycholic acid (UDCA) and the epimeric isomer, chenodeoxycholic acid (CDCA), in their synthetic mixtures and in tablet dosage form. The proposed HPLC method uses a C18 column and mobile phase consisting of an acetonitrile–phosphate buffer mixture (pH 2.3, 100 mM; 50 + 50, v/v) at a flow rate of 2.0 mL/min with UV detection at 210 nm. The method was validated according to the International Conference on Harmonization guidelines; and linearity, range,accuracy, precision, robustness,and system suitability were studied. The LOD and LOQ were also calculated and found to be 1.23 and 3.73 μg/mL for UDCA and 0.83 and 2.52 μg/mL for CDCA, respectively. The method was adapted for UHPLC, in which baseline separation was achieved in <2.5 min. The assay results of Ursomix tablets by the developed method were statistically compared with those obtained by the reference method using t- and F-tests, and no significant differences were observed.

scholarly journals HPLC Analytical Method Validation for Determination of Cefotaxime in the Bulk and Finished Pharmaceutical Dosage Form

2020 ◽  
pp. 33-42 ◽  
Author(s):  
Mostafa F. Al-Hakkani
Keyword(s):  
Method Validation ◽  
Analytical Method ◽  
Pharmaceutical Formulations ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Analytical Method Validation ◽  
Antibiotic Drugs ◽  
Wide Scale

Cefotaxime (Cfm) is a member of the third generation of the Cephalosporin antibiotics. It used on a wide scale in prescribed antibiotic drugs as anti-infection for gram-positive microorganisms and gram-negative microorganisms. The present study aimed to develop an HPLC method of Cfm analysis enjoyed highly linearity, repeatability, robustness, ruggedness, selectivity, rapidly and economical to use. The chromatographic method uses a reversed phase column BDS column (150 mm x 4.0 mm x 5 μm). The mobile phase was prepared by mixing Methanol: Phosphate buffer (1000 mL : 130 mL) and the pH was adjusted to 6.15 at isocratic flow rate 1.0 mL/min with PDA detector at 235nm, column oven adjusted at 30°C and injection volume 20 μL. The method revealed that satisfied linearity regression R2 (0.9992) with repeatability (0.15%) with DL and QL; 35.5 ng/mL and 107.6 ng/mL respectively. The method showed a successful application of analytical method validation for Cfm in bulk and pharmaceutical formulations.

scholarly journals Development and validation of RP-HPLC method for estimation of Vildagliptin from table dosage form

2012 ◽  
Vol 1 (1) ◽  
Author(s):  
Aparajita Malakar ◽  
Bishwajit Bokshi ◽  
Dilruba Nasrin
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Phase 1 ◽  
Ammonium Hydroxide ◽  
Reversed Phase ◽  
Hplc Method ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Limit Of Quantitation

A new simple, specific, precise and accurate reversed-phase liquid chromatography method has been developed for the determination of Vildagliptin (VLG) in pharmaceutical dosage form. The separation was achieved on a Xterra® Waters C18 column (150mm×4.6mm, 5?m) using mobile phase consisting of a mixture of aqueous phase (1 ml of 25% ammonium hydroxide was dissolved in 1000 ml of water for chromatography, pH of the solution was adjusted to the value of 9.5 using a 50% solution of phosphoric acid) and organic phase (methanol) in the ratio of 60:40 v/v at a flow rate of 1.0 ml/min. Detection was carried out at 210nm. The retention time of Vildagliptin was found to be 6.3 min. The calibration curve was found linear between 5- 200?g/ml (r2 = 0.9997). Limit of detection and limit of quantitation were 1.47 and 4.90 ?g/mL, respectively. The percentage recoveries of Vildagliptin were found to be in the range of 99.11-100.62%. The method was validated in accordance with International Conference on Harmonization acceptance criteria for specificity, linearity, precision, accuracy, robustness and system suitability. The excipients did not interfere in the determination of VLG. The proposed method was successfully applied for the quantitative analysis of VLG in tablet dosage form, which will help to improve quality control. DOI: http://dx.doi.org/10.3329/ijpls.v1i1.12947 International Journal of Pharmaceutical and Life Sciences Vol.1(1) 2012

NEW VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF RIZATRIPTAN BENZOATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (12) ◽  
pp. 32-36
Author(s):  
T. Vishalakhi ◽  
◽  
S. K Kumar ◽  
K Sujana ◽  
P Rani
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Detector Response ◽  
Mobile Phase Flow Rate ◽  
Pharmaceutical Dosage Form ◽  
Rizatriptan Benzoate ◽  
Rp Hplc ◽  
Bulk Drug

A simple validated RP HPLC method for the estimation of rizatriptan benzoate in pharmaceutical dosage form and bulk was developed for routine analysis. This method was developed by selecting Agilent TC C18 (250 x 4.6 mm, 5 μ) column as stationary phase and acrylonibrile:water (45:55), pH adjusted to 3, as mobile phase. Flow rate of mobile phase was maintained at 4: 1 mL/min at ambient temperature throughout the experiment. Quantification was achieved with ultraviolet (DAD) detection at 220 nm. The retention time obtained for rizatriptan was 2.8 min. The detector response was linear in the concentration range of 2-25μg/mL. This method was validated and shown to be specific, sensitive, precise, linear, accurate, rugged and robust. Hence, this method can be applied for routine quality control of rizatriptan benzoate in dosage forms as well as in bulk drug.

VALIDATED RP-HPLC METHOD FOR DETERMINATION OF ENZALUTAMIDE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (11) ◽  
pp. 46-50
Author(s):  
Z. G Khan ◽  
◽  
S. S. Patil ◽  
P. K. Deshmukh ◽  
P. O. Patil
Keyword(s):  
Retention Time ◽  
Mobile Phase ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detector ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Bulk Drug

Novel, isocratic reversed phase high performance liquid chromatography method was developed and validated for the determination of enzalutamide (EZA) in bulk drug and pharmaceutical formulation. Efficient separation was achieved on PrincetonSPHER C18 100A, 5μ (250×4.6 mm) under the isocratic mode of elution using acetonitrile: water (80:20) % V/V as a mobile phase pumped in to the column at flow rate 1.0 mL/min. The effluent was monitored at 237.0 nm using UV detector. EZA was eluted in the given mobile phase at retention time (tR) of 3.2 minutes. The standard calibration curve was linear over the concentration range 10 - 60 μg/mL with correlation coefficient 0.997. The method was validated for accuracy, precision, sensitivity, robustness, ruggedness and all the resulting data treated statistically. The system suitability parameters like retention time, theoretical plates, tailing factor, capacity factor were found within the limit.

Simultaneous determination of Sulphadoxine and Pyrimethamine by taking Tolterodine as an internal standard in Pharmaceutical dosage form by RP-HPLC

2021 ◽  
pp. 145-150
Author(s):  
Sushil D. Patil ◽  
Pravin B. Shelke ◽  
Priti Aher ◽  
Maswood Ahmed Hafizur Rahman
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Internal Standard ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Sulphadoxine Pyrimethamine

A simple, rapid, economic, sensitive and precise HPLC method has been developed for the simultaneous determination of Sulphadoxine and Pyrimethamine in pharmaceutical dosage form by taking Tolterodine as an internal standard. The method was carried out using Phenomenex C18 (4.6ID × 250mm; 5µm) column and mobile phase comprised of methanol and Phosphate Buffer in proportion of ratio 60:40 v/v. The flow rate was 1.0mL/min and detection was carried out at 276nm. The retention time of Sulphadoxine, Pyrimethamine and Tolterodine were found to be 2.967, 4.058 and 6.908 respectively. Linearity of Sulphadoxine and Pyrimethamine in the range of 2 to 12μg/mL and 4 to 24μg/mL respectively. The % recoveries of Sulphadoxine and Pyrimethamine were found to be in between 99.93% to 99. 96 % respectively. The proposed method is suitable for the routine quality control analysis for simultaneous determination of Sulphadoxine and Pyrimethamine was in bulk and pharmaceutical dosage form.

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