scholarly journals Stability-Indicating Method for Determination of Oxyphenonium Bromide and Its Degradation Product by High-Performance Liquid Chromatography

2007 ◽  
Vol 90 (5) ◽  
pp. 1250-1257 ◽  
Author(s):  
Alaa EL-Gindy ◽  
Samy Emara ◽  
Heba Shaaban
Keyword(s):  
Degradation Product ◽  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
Order Rate Constant ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Stability Indicating Method ◽  
Oxyphenonium Bromide

Abstract A high-performance liquid chromatographic (HPLC) method was developed for determination of oxyphenonium bromide (OX) and its degradation product. The method was based on the HPLC separation of OX from its degradation product, using a cyanopropyl column at ambient temperature with mobile phase of acetonitrile25 mM potassium dihydrogen phosphate, pH 3.4 (50 + 50, v/v). UV detection at 222 nm was used for quantitation based on peak area. The method was applied to the determination of OX and its degradation product in tablets. The proposed method was also used to investigate the kinetics of the acidic and alkaline degradation of OX at different temperatures, and the apparent pseudo first-order rate constant, half-life, and activation energy were calculated. The pH-rate profile of the degradation of OX in Britton-Robinson buffer solutions within the pH range 212 was studied.

scholarly journals RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN IN BULK AND TABLET DOSAGE FORM

2018 ◽  
Vol 1 (2) ◽  
pp. 61-64
Author(s):  
Upendra Bhadoriya ◽  
Hemant Dhaked ◽  
Abhinandan Kumar Danodia
Keyword(s):  
High Performance ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Reverse Phase ◽  
Tablet Dosage

A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Telmisartan in bulk and tablet dosage forms. It was found that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on RP18, column (250×4.6mm) with a mobile phase composed of 0.025M potassium dihydrogen phosphate : acetonitrile : methanol (45:50:5) at a flow rate of 1ml/min. The detection was monitored at 216 nm. The calibration curve for Telmisartan was linear from 100 to 500 ng/ml. The interday and intraday precision was found to be within limits. LOD and LOQ for Telmisartan were found to be 27 ng/ml and 83 ng/ml. Accuracy and reproducibility were also found within range. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of Telmisartan in bulk and its tablet dosage forms.

scholarly journals Simultaneous HPLC Determination of Chlordiazepoxide and Mebeverine HCl in the Presence of Their Degradation Products and Impurities

2015 ◽  
Vol 2015 ◽  
pp. 1-9
Author(s):  
Rania N. El-Shaheny ◽  
Fathalla F. Belal
Keyword(s):  
Simultaneous Determination ◽  
Degradation Product ◽  
Mobile Phase ◽  
Degradation Products ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Ir Studies ◽  
Validation Procedure

A simple, rapid, and sensitive RP-HPLC method was developed and validated for the simultaneous determination of chlordiazepoxide (CDO) and mebeverine HCl (MBV) in the presence of CDO impurity (2-amino-5-chlorobenzophenone, ACB) and MBV degradation product (veratric acid, VER). Separation was achieved within 9 min on a BDS Hypersil phenyl column (4.5 mm × 250 mm, 5 µm particle size) using a mobile phase consisting of acetonitrile: 0.1 M potassium dihydrogen phosphate: triethylamine (35 : 65 : 0.2, v/v/v) in an isocratic mode at a flow rate of 1 mL/min. The pH of the mobile phase was adjusted to 4.5 with orthophosphoric acid and UV detection was set at 260 nm. A complete validation procedure was conducted. The proposed method exhibited excellent linearity over the concentration ranges of 1.0–100.0, 10.0–200.0, 2.0–40.0, and 2.0–40.0 µg/mL for CDO, MBV, VER, and ACB, respectively. The proposed method was applied for the simultaneous determination of CDO and MBV in their coformulated tablets with mean percentage recoveries of 99.75 ± 0.62 and 98.61 ± 0.38, respectively. The results of the proposed method were favorably compared with those of a comparison HPLC method using Studentt-test and the variance ratioF-test. The chemical structure of MBV degradation product was ascertained by mass spectrometry and IR studies.

scholarly journals STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN AND METFORMIN IN PHARMACEUTICAL DOSAGE FORM

2017 ◽  
Vol 9 (3) ◽  
pp. 150
Author(s):  
Ramesh Jayaprakash ◽  
Senthil Kumar Natesan
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc

Objective: The present study was aimed to develop a rapid, accurate, linear, sensitive and validate stability-indicating high performance liquid chromatographic [RP-HPLC] method for determination of vildagliptin and metformin in pharmaceutical dosage form.Methods: The chromatographic separation was performed on kromasil-C18 column [4.5 x 250 mm; 5 µm] using a mobile phase consisting of 0.05 mmol potassium dihydrogen phosphate buffer: acetonitrile [80:20 v/v], [pH adjusted to 3.5 using orthophosphoric acid]. The flow rate is 0.9 ml/min and the detection was carried out at 263 nm.Results: The chromatographic condition, the peak retention time of metformin and vildagliptin were found to be 2.215 min and 2.600 min respectively. Stress testing was performed in accordance with an international conference on harmonization [ICH] Q1A R2 guidelines. The method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 5-17.5 µg/ml and 50-175 µg/ml for vildagliptin and metformin. The limit of detection and quantification was found to be 0.0182 µg/ml and 0.0553 µg/ml for vildagliptin and 0.4451 µg/ml and 1.3490 µg/ml for metformin respectively.Conclusion: A new sensitive, simple and stability indicating reverse-phase high-performance liquid chromatography [RP-HPLC] method has been developed and validated for the determination of vildagliptin and metformin. The proposed method can be used for routine determination of vildagliptin and metformin.

Development and Validation of Stability Indicating High-Performance Liquid Chromatographic Method for Determination of Cyproheptadine Hydrochloride, its Impurity And Degradation Product

2020 ◽  
Author(s):  
Maha M Abdelrahman ◽  
Eglal A Abdelaleem ◽  
Nouruddin W Ali ◽  
Raghda A Emam
Keyword(s):  
Degradation Product ◽  
High Performance ◽  
Oxidative Degradation ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Good Resolution ◽  
Intermediate Precision ◽  
Rp Hplc

Abstract This work presents a sensitive, accurate and selective RP-HPLC method for simultaneous determination of cyproheptadine HCl (CPH), its impurity B (dibenzosuberone) and CPH oxidative degradation product (10,11-dihydroxy-dibenzosuberone) in bulk powder and in pharmaceutical formulation. The RP-HPLC method depends on isocratic elution using C8 column and mobile phase consisting of 0.05 M KH2PO4 buffer:methanol (35:65, v/v, pH = 4.5) at a flow rate of 2 mL/min, and the eluant was monitored at 245 nm. Good resolution was obtained with tR values of 3.05, 7.54 and 6.17 min for CPH, impurity and oxidative degradate, respectively. The proposed method has been validated as per ICH guidelines using pure forms of CPH, its impurity and degradation product in pharmaceutical formulation with an accuracy of 100.48, 100.16 and 100.11, respectively. Additional spiking experiments yielded an accuracy of 100 ± 1.6%. Repeatability and intermediate precision results indicated acceptable low <2% RSD values. Moreover, the developed method’s statistical results were favorably compared to the previously reported method results regarding both accuracy and precision. The developed method can be applied for analysis of the three components in quality control laboratories.

scholarly journals Simultaneous Estimation of Satranidazole and Ofloxacin in Tablet Dosage Form by High Performance Liquid Chromatography

2010 ◽  
Vol 7 (1) ◽  
pp. 198-202 ◽  
Author(s):  
R. Shinde Sachin ◽  
I. Bhoir Suvarna ◽  
S. Pawar Namdev ◽  
B.Yadav Suman ◽  
M. Bhagwat Ashok
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
Standard Addition ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Tablet Dosage

A Simple, fast and precise reversed phase high performance liquid chromatographic method is developed for the simultaneous determination of satranidazole and ofloxacin. Chromatographic separation of these drugs were performed on Kromasil C18column (250 x 4.6 mm, 5 µ) as stationary phase with a mobile phase comprising of 20 mM potassium dihydrogen phosphate: acetonitrile in the ratio of 60:40 (v/v) containing 0.1% glacial acetic acid at a flow rate of 1 mL/min and UV detection at 318 nm. The linearity of satranidazole and ofloxacin were in the range of 1.5 to 3.6 µg/mL and 1.0 to 2.4 µg/mL respectively. The recovery was calculated by standard addition method. The average recovery was found to be 100.63% and 100.02% for satranidazole and ofloxacin respectively. The proposed method was found to be accurate, precise and rapid for simultaneous determination of satranidazole and ofloxacin

scholarly journals Simultaneous Quantification of Ciprofloxacin, Quinine and 3-hyrdoxyquinine in Human Plasma using a HPLC Method

2016 ◽  
Vol 8 (1) ◽  
pp. 11 ◽  
Author(s):  
Adebanjo J. Adegbola ◽  
Julius O. Soyinka
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Therapeutic Monitoring ◽  
Dihydrogen Phosphate ◽  
Antimalarial Therapy ◽  
Liquid Chromatographic

Malaria has been shown to strongly predispose patients in areas of malaria endemicity to bacteremia with severe outcomes, thus justifying the use of antibiotics in combination with antimalarial therapy in patients with severe malaria. This study describes a High-Performance Liquid Chromatographic (HPLC) method for simultaneous determinations of Ciprofloxacin (CPN), Quinine (QN), and its major metabolite, 3-Hydroxyquinine (3-HQN), in human plasma. Following a simple precipitation with acetonitrile, chromatographic separation was achieved on a reversed-phase Agilent Zorbax (CN) column (5 μm, 150 X 4.6 mm i.d) using a mobile phase consisting of acetonitrile: potassium dihydrogen phosphate (pH = 2.8; 0.02 M) (42:58, v/v). Retention times for CPN, 3-HQN, IS and QN were 2.7, 3.3, 3.6 and 4.9 minutes respectively. The limits of detection and validated lower limits of quantitation were 30 and 70 ng/ml for both QN and 3-HQN while the corresponding values were 50 and 100 ng/ml for CPN, respectively. The new HPLC method here developed, when compared with previous methods for the analysis of either or both drugs is simple, rapid, selective, reproducible and costeffective. It is also suitable for conducting a simultaneous therapeutic monitoring of quinine and ciprofloxacin in patients when concomittantly administered as demonstrated in five healthy volunteers.

scholarly journals Method development and Validation of RP-HPLC method for the Determination of Olanzapine in Bulk and Tablet Dosage form

2017 ◽  
Vol 10 (5) ◽  
pp. 281
Author(s):  
Sv Saibaba ◽  
Shanmuga Pandiyan P
Keyword(s):  
High Performance ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Reverse Phase ◽  
Relative Standard ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: To develop and validate reverse phase-high performance liquid chromatographic method for estimation of olanzapine in bulk and tablet dosage form.Methods: Chromatographic analysis was performed on XTerra C18 (150×3.5 mm inner diameter, 5 μm) column using a mobile phase consisting of buffer (potassium dihydrogen phosphate) and methanol (45:55% v/v) with a flow rate of 0.6 ml/minutes. The detection was carried out at 247 nm.Results: The calibration curve of olanzapine was linear in the range of 30-70 μg/ml. The mean % assay of marketed formulation was found to be 100.2%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%.Conclusion: The developed method is simple, precise and rapid, making it suitable for estimation of olanzapine in bulk and tablet dosage form.Keywords: Olanzapine, Reverse phase-high performance liquid chromatographic, Validation.

scholarly journals A Rapid Reversed-Phase HPLC Method for Analysis of Trans-Resveratrol in PLGA Nanoparticulate Formulation

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Gurinder Singh ◽  
Roopa S. Pai
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
Potassium Dihydrogen Phosphate ◽  
Plga Nanoparticles ◽  
Reversed Phase ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Relative Standard ◽  
New Formulation

A rapid reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of trans-resveratrol (t-RVT) in PLGA nanoparticle formulation. A new formulation of t-RVT loaded PLGA nanoparticles (NPs) with potential stealth properties was prepared by nanoprecipitation method in our laboratory. The desired chromatographic separation was achieved on a Phenomenex C18 column under isocratic conditions using UV detection at 306 nm. The optimized mobile phase consisted of a mixture of methanol: 10 mM potassium dihydrogen phosphate buffer (pH 6.8): acetonitrile (63 : 30 : 7, v/v/v) at a flow rate of 1 mL/min. The linear regression analysis for the calibration curves showed a good linear correlation over the concentration range of 0.025–2.0 μg/ml, with determination coefficients, R2, exceeding 0.9997. The method was shown to be specific, precise at the intraday and interday levels, as reflected by the relative standard deviation (RSD) values, lower than 5.0%, and accurate with bias not exceeding 15% and percentage recovery was found to be in the range between 94.5 and 101.2. The limits of detection and quantification were 0.002 and 0.007 μg/ml, respectively. The method was successfully applied for the determination of t-RVT encapsulation efficiency.

scholarly journals A quantitative HPLC method for simultaneous determination of prodrug of voriconazole and voriconazole in beagle plasma, and its application to a toxicokinetic study

2021 ◽  
Author(s):  
Yufa Wen ◽  
Shuang Chen ◽  
Yanjuan Yuan ◽  
Qing Shao ◽  
Xuejun He ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
Internal Standard ◽  
Storage Conditions ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Different Temperatures ◽  
Reproducible Method

AbstractA simple, rapid, efficient and reproducible method based on High Performance Liquid Chromatography (HPLC) for simultaneous determination of prodrug of voriconazole (POV) and voriconazole in beagle plasma has been established and validated. Omeprazole was utilized as the sole internal standard. Analytes and internal standards were extracted through protein precipitation and separated on a Venusil XBP C18 chromatography column (4.6 × 250 mm, 5 µm). The mobile phase was methanol and 20 mmol/L potassium dihydrogen phosphate. Chromatographic separation was achieved by using an isocratic elution procedure that used 65% methanol and a flow rate of 1 mL/min. The ultraviolet (UV) detection wavelength was 256 nm and the total running time was 15 min. This method showed good linear ranges of 100–75,000 ng/mL for voriconazole prodrug and 200–100,000 ng/mL for voriconazole respectively. The precision and accuracy were acceptable. Analytes in plasma samples are stable under different temperatures and storage conditions. The developed HPLC method has been successfully applied to the studies of toxicokinetics of POV after intravenous drip in beagle and provided important information for the further development and application.

scholarly journals Simultaneous Determination of Aceclofenac, Paracetamol and Chlorzoxazone by HPLC in Tablet Dose Form

2009 ◽  
Vol 6 (1) ◽  
pp. 289-294 ◽  
Author(s):  
Uttam D. Pawar ◽  
Abhijit V. Naik ◽  
Aruna V. Sulebhavikar ◽  
Tirumal A. Datar ◽  
Kiran. V. Mangaonkar
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Standard Addition ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Dihydrogen Phosphate ◽  
Limit Of Quantification

A simple, fast and precise reversed phase high performance liquid chromatographic method is developed for the simultaneous determination of aceclofenac, paracetamol and chlorzoxazone. Chromatographic separation of the three drugs was performed on an Intersil C18column (250 mm × 4.6 mm, 5µm) as stationary phase with a mobile phase comprising of 10 mM potassium dihydrogen phosphate (pH adjusted to 5.55 with ammonia): acetonitrile in the ratio 60:40 (v/v) at a flow rate of 1.0 mL/min and UV detection at 205 nm. The linearity of aceclofenac, paracetamol and chlorzoxazone were in the range of 5.00-15.00 µg/µL, 25.00-75.00 µg/µL and 25.00-75.00 µg/µL respectively. The limit of detection for aceclofenac, paracetamol and chlorzoxazone was found to be 18.0 ng/mL, 22.0 ng/mL and 9.0 ng/mL respectively whereas, the limit of quantification was found to be 55 ng/mL, 65 ng/mL and 27.0 ng/mL respectively. The recovery was calculated by standard addition method. The average recovery was found to be 99.04%, 99.57% and 101.63% for aceclofenac, paracetamol and chlorzoxazone respectively. The proposed method was found to be accurate, precise and rapid for the simultaneous determination of aceclofenac, paracetamol and chlorzoxazone

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