scholarly journals Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets

2016 ◽  
Vol 66 (4) ◽  
pp. 479-490 ◽  
Author(s):  
Said A. Hassan ◽  
Eman S. Elzanfaly ◽  
Salem Badr A. El-Zeany ◽  
Maissa Y. Salem
Keyword(s):  
Capillary Electrophoresis ◽  
Degradation Products ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Acidic Degradation ◽  
Development And Validation ◽  
First Time ◽  
Hydrolysis Of

Abstract Two methods were developed for separation and quantitation of amlodipine (AML) and atorvastatin (ATV) in the presence of their acidic degradation products. The first method was a simple isocratic RP-HPLC method while the second was capillary electrophoresis (CE). Degradation products were obtained by acidic hydrolysis of the two drugs and their structures were elucidated for the first time by IR and MS spectra. Degradation products did not interfere with the determination of either drug and the assays were therefore stability-indicating. The linearity of the proposed methods was established over the ranges 1-50 μg mL-1 for AML and ATV in the HPLC method and in the range of 3-50 and 4-50 μg mL-1 for AML and ATV, respectively, in the CE method. The proposed methods were validated according to ICH guidelines. The methods were successfully applied to estimation of AML and ATV in combined tablets.

scholarly journals Development and validation of a new analytical RP-HPLC method for simultaneous determination of Glibenclamide and Atenolol in bulk

2019 ◽  
Vol 10 (3) ◽  
pp. 2433-2445
Author(s):  
Anitha P ◽  
Ramkanth S ◽  
Satyanarayana S V
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Development And Validation ◽  
First Time

A new, simple, reliable, fast, sensitive and economical RP-HPLC method was developed and validated for simultaneous estimation of two fixed-dose combinations frequently prescribed in coexisted chronic diseases such as diabetes (GLB) and hypertension (ATN) in bulk for the first time. The mobile phase used for the chromatographic runs consisted of 0.01N potassium dihydrogen ortho phosphate (pH 4.8) and acetonitrile (55:45, v/v). The separation was achieved on column (BDS C18 250 x 2.1mm, 1.6m) using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 235.0 nm. The method was linear at the concentration range 2.5-15µg/ml for Glibenclamide (GLB) and 6.25-37.5µg/ml for Atenolol (ATN), respectively. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The method was validated for system suitability, linearity, accuracy, precision, detection, quantification limits and robustness and was found it is acceptable in the range of 2.5–15 µg/ml for GLB and 6.25–37.5 µg/ml for ATN. The LOD and LOQ of GLB was found to be 0.48 µg/ml and 1.47µg/ml and for ATN was found to be 0.72µg/ml and 2.20 µg/ml, respectively. The method was applied to drug interaction studies of GLB with ATN to illustrate the scope and application of the methods to manage two different therapeutic classes of drugs, as they may co-administered in concurrent diseases.

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug

2010 ◽  
Vol 3 (2) ◽  
pp. 978-986
Author(s):  
Wamorkar V V ◽  
C S Ramaa ◽  
Manjunath S Y ◽  
V Malla Reddy
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Good Resolution ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation ◽  
Different Levels

RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the stress conditions such as acid, base, oxidation, heat and light as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, mobile phase composition and allied columns. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

2021 ◽  
pp. 4767-4772
Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Solution Stability ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

Simple and Sensitive Analytical Method Development and Validation of Nitazoxanide and Ofloxacin by RP- HPLC

2021 ◽  
pp. 84-86
Author(s):  
Abhishek Agrawal ◽  
Prem Kumar Bichala ◽  
Swapna Singh
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Laboratory ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

RP-HPLC method was developed for the determination for the validation of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. Chromatographic separation was performed on Develosil ODS HG-5 RP C18, 15x4.6mm, 5µm column, with mobile phase comprising of mixture of ACN: Methanol: Citric acid in the ratio of 50:45:5 v/v, at the flow rate 1.0ml/min and the detection was carried out at 296nm. The comprehensive forced stress testing has been carried out as per USP guidelines. The drug Nitazoxanide is subjected to synthetic Benzamide, and the drug Ofloxacin is subject to synthetic Fluoroquinolone. RP- HPLC method was developed to separate analyte from all other degradation peaks. The method was successfully validated as per ICH guidelines for the purpose of conducting studies of the analyte in quality control laboratory. The drug was subjected to different degradation conditions; it was found to be stable in all degradation conditions. The purposed HPLC method was found to be precise, specific, accurate, rapid and economical for the determination of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. The sample recoveries in all formulations were in good agreement with their respective label claims and this method can be used for routine analysis. The linearity range was found to be 0-50 (µg/ml) for Nitazoxanide and 0-50 (µg/ml) for Ofloxacin. Calibration curve was plotted and correlation co-efficient for the drugs found to be 0.999 and 0.997. Hence the results obtained were within the limits.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR RILPIVIRINE HYDROCHLORIDE IN BULK AND USE IN ANALYSIS OF PREPARED NANOSUSPENSION

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (04) ◽  
pp. 42-46
Author(s):  
Madhuri Manchala ◽  
◽  
Vijaya Sri Kanagala ◽  
Ganapath Vinay Jain
Keyword(s):  
Homogenization Method ◽  
Hplc Method ◽  
Array Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Photodiode Array Detector ◽  
Photodiode Array ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise, accurate and robust RP-HPLC-PDA method was developed and validated for the determination of rilpivirine hydrochloride in tablet dosage forms. Reverse-phase chromatography was performed on a BDS hypersil (250 mm × 4.6 mm, 6 μm) column of Waters HPLC with Empower software and with a photodiode array detector. Methanol: acetonitrile: water 80:13.5:6.5 (v/v) was used as the mobile phase at a flow rate of 1 mL min-1 with PDA detection at 306 nm. Rilpivirine hydrochloride nanosuspension was prepared by using an ultrasonic homogenization method. Linearity was observed in the concentration range of 0.1–10 μg mL-1 with regression equation y = 508856X+46908 (R2 = 0.9998). The method was validated as per ICH guidelines. The RSD for intra-day (1.31- 0.67) and inter-day (1.69-1.59) precision was found to be less than 2%. The developed method is simple, precise and robust for the determination of rilpivirine hydrochloride and is successfully applied for the nanosuspension.

scholarly journals Validated stability indicating gradient RP-HPLC method for the estimation of antihypertensive drugs in bulk and pharmaceutical dosage forms

2012 ◽  
Vol 1 (11) ◽  
pp. 336-341 ◽  
Author(s):  
Napa Delhi Raj ◽  
Sockalingam Anbazhagan ◽  
Kunapareddy Anudeep Babu ◽  
Sunkara Narendra Babu ◽  
Chusena Narasimharaju Bhimanadhuni
Keyword(s):  
Antihypertensive Drugs ◽  
Degradation Products ◽  
Olmesartan Medoxomil ◽  
Pharmaceutical Journal ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines

A rapid and precise RP-HPLC method for determination of Olmesartan medoxomil and Hydrochlorothiazide in bulk and pharmaceutical dosage forms. Olmesartan medoxomil & Hydrochlorothiazide are found to be degraded together under different set of conditions as followed according to ICH guidelines and the degradants so formed along with olmesartan & hydrochlorothiazide are separated by using INERTSIL ODS C18 3V (150 x 4.6, 5µ) using mobile phase 1ml triethanolamine in one litre water and the pH was adjusted to 2.5 with orthophosphoric acid and acetonitrile using a gradient program with a flow rate of 1ml/min, throughout the gradient program with a detection wavelength of 225nm for both the compounds with a injection volume of 10µl. The method was validated for selectivity, linearity, accuracy, robustness, precision and specificity. The results were indicating the method was selective in analysis of both olmesartan medoxomil and hydrochlorothiazide in the presence of degradation products formed under various stress conditions.DOI: http://dx.doi.org/10.3329/icpj.v1i11.12058 International Current Pharmaceutical Journal 2012, 1(11): 336-341

scholarly journals Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Sofosbuvir, Velpatasvir, and Voxilaprevir in Tablet Formulation

2020 ◽  
pp. 7-14
Author(s):  
Deepthi R ◽  
Gowri Sankar D
Keyword(s):  
High Performance ◽  
Hplc Method ◽  
Solution Stability ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Optimized Conditions

Objective: The present study aimed to develop a stability-indicating reverse-phase high performance-liquid chromatography (RP-HPLC) method for the estimation of Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form and validated in accordance with ICH guidelines. Methods: The optimized conditions for the developed RP-HPLC method are Agilent C18 (250 mm×4.6mm, 5μ) column maintained at 30ºC with a mobile phase consisting of Buffer(0.1%OPA) and Acetonitrile taken in the ratio 55:45%v/v on isocratic mode at flow rate 1.0ml/min. The sample was detected at 220 nm. Results: The retention time of Sofosbuvir, Velpatasvir, and Voxilaprevir was found to be 2.17, 2.731 and 3.55 min respectively. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness and solution stability.

scholarly journals Isolation, Characterization & Phytochemical Screening, Analytical Method Development and Validation for the Determination of Catechins in B.ciliata by RP HPLC Method

2020 ◽  
Vol 13 (2) ◽  
pp. 18-24
Author(s):  
NDVR Saradhi ◽  
N Madan Gopal ◽  
C Madhusudhna Chetty ◽  
K Sushmitha
Keyword(s):  
Method Development ◽  
Analytical Procedure ◽  
Biological Activities ◽  
Research Work ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Crude Plant Extract ◽  
Development And Validation

Ayurveda, an ancient system of medicines detailing a number of medicinal plants and their activities in human or animals. The present research work was aimed to develop an analytical procedure for the determination of catechins in the selected plant - B.Ciliata. It is famously known as stone flower/ stone breaker having various biological activities like anti urolithiatic, antiviral, antidiabetic antitumor and cardio protective activity. The methanolic extract of the plant is isolated and a method is developed by using RP HPLC for the determination of catechins in the crude plant extract using a C18 column (200*4.6mm, 5μ) and detected at 241 nm. The method is validated for its system suitability, Linearity, Accuracy, Precision, Robustness and sensitivity as per the ICH guidelines Q2(R1) to meet the analytical procedure in academic and industrial usage

scholarly journals Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Ceftaroline Fosamil in Bulk and Its Parenteral Dosage Forms

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
A. Suneetha ◽  
K. China Venkanna
Keyword(s):  
Degradation Products ◽  
Active Pharmaceutical Ingredient ◽  
Dosage Forms ◽  
Hplc Method ◽  
Assay Method ◽  
Pharmaceutical Dosage Forms ◽  
Ceftaroline Fosamil ◽  
Rp Hplc ◽  
Development And Validation

The present method describes the development of a validated RP-HPLC method for determination of ceftaroline fosamil in presence of its degradation products or other pharmaceutical excipients. The drug substance was subjected to stress conditions of acid, alkali, and oxidative and thermal degradation studies. Separation was carried out on a C-18 X-terra column (Waters Corporation, 250 mm × 4.6 mm I.D.; particle size 5 μm) using 40 : 30 : 30 [buffer : acetonitrile : methanol] as mobile phase at a flow rate of 1.0 ml/min. UV detection was performed at 242 nm. The method was validated with respect to specificity, selectivity, linearity, accuracy, precision, and robustness. The assay method was found to be linear in the range of 40 to 120 μg/mL with a correlation coefficient of 0.9999. The percentage recovery of active pharmaceutical ingredient from parenteral dosage form ranged from 99.5 to 100.2%. The method precision for determination of ceftaroline was below 0.85%. The results showed that the developed RP-HPLC method is suitable for determination of ceftaroline fosamil in bulk as well as stability samples of pharmaceutical dosage forms containing various excipients.

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