Stability-Indicating Reverse Phase HPLC Method for the Determination of Cefazolin

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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Development and Validation of Reverse Phase HPLC Method for Enantiomer Excess Determination of Tenofovir Disoproxil Fumarate drug Substance

Asian Journal of Research in Chemistry ◽

10.5958/0974-4150.2020.00064.4 ◽

2020 ◽

Vol 13 (5) ◽

pp. 334-340

Author(s):

Ch. Ramesh ◽

D. Rama Devi ◽

MNB. Srinivas ◽

Nagaraju Rajana ◽

S. Radha Krishna ◽

...

Keyword(s):

Tenofovir Disoproxil Fumarate ◽

Hplc Method ◽

Drug Substance ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Enantiomer Excess ◽

Development And Validation

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APPLICATION OF VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF ARMODAFINIL IN BULK AND FORMULATION

International Journal of Current Pharmaceutical Research ◽

10.22159/ijcpr.2017v9i5.22162 ◽

2017 ◽

pp. 158-161

Author(s):

Devi Ramesh ◽

Mohammad Habibuddin

Keyword(s):

Retention Time ◽

Mobile Phase ◽

Hplc Method ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Rp Hplc ◽

Ich Guidelines ◽

Validation Parameters ◽

Isocratic Mode

Objective: The objective of the present study is to develop and validate a simple, rapid, sensitive reverse phase HPLC method for the determination of Armodafinil present in bulk and its pharmaceutical formulations.Methods: The chromatographic separation was achieved by using Hypersil ODS C-18 (150 x 4.6 mm, 5Âµ) in an isocratic mode with mobile phase methanol: phosphate buffer 3.0 (60:40 %v/v) was used. The flow rate was 1 ml/min and effluent was monitored at 225 nm. The method was validated for validation parameters i.e. linearity, accuracy, precision and robustness according to ICH guidelines.Results: The retention time of Armodafinil was 4.2 min and the linearity range of the method was 500-20000ng/ml with regression (r2) coefficient 0.9998. The method was validated for precision, accuracy, robustness and which were found to be within the acceptable limits according to the ICH guidelines. Also, the method was successfully applied for the estimation of Armodafinil in the marketed formulation of Nuvigil and the recovery was found to be>98%.Conclusion: The developed method possess good selectivity, specificity, there is no interference found in the blank at a retention time of ARM and good correlation between the peak area and concentration of the drugs under prescribed conditions. Hence, the method can be applied for routine analysis of Armodafinil.Â

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Validated Reverse Phase HPLC Method for the Determination of DEHP Content in Reconstituting Diluents and in Reconstituted Solutions of Imipenem and Cilastatin for Injection

E-Journal of Chemistry ◽

10.1155/2010/805248 ◽

2010 ◽

Vol 7 (2) ◽

pp. 501-513 ◽

Cited By ~ 2

Author(s):

A. K. Chaudhary ◽

S. Ankushrao Waske ◽

S. Yadav ◽

T. G. Chandrashekhar ◽

Vandana Singh

Keyword(s):

Hplc Method ◽

Beta Lactam ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Limit Of Quantification ◽

Quality Control Tool ◽

Lactam Antibiotic ◽

Unique Method ◽

Pre Treatment

A simple, rapid, accurate and economic reverse phase HPLC method was developed and validated for determination of di-(2-ethylhexyl)phthalate (DEHP) in reconstituting diluents and reconstituted solutions of imipenem and cilastatin for injection The method was applied to detect any leaching enhancement in presence of imipenem and cilastatin in reconstituted injections. Imipenem and cilastatin for injection is a widely used broad spectrum beta-lactam antibiotic. As per requirements of various regulatory authorities of different countries, DEHP content needs to be monitored in the reconstituting diluents used to reconstitute injections. The proposed method is a unique method wherein DEHP can be determined directly without any sample pre-treatment before analysis. The method can be used as a good quality control tool to control the leaching of DEHP in the reconstituting diluents and reconstituted injections. The method utilizes C18column (250 × 4.6 mm, 5μ) and a mixture of methanol, propan-2-ol and water as mobile phase. DEHP was detected at 225 nm. The method has low limit of quantification (0.058 μg mL-1) which is much below the acceptance limit calculated as per USFDA tolerance criteria (3.5 μg mL-1for adults and 0.3 μg mL-1for neonates and infants).

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Validated Reverse Phase HPLC Method for the Determination of Impurities in Etoricoxib

E-Journal of Chemistry ◽

10.1155/2011/726385 ◽

2011 ◽

Vol 8 (s1) ◽

pp. S119-S126

Author(s):

S. Venugopal ◽

U. M. Tripathi ◽

N. Devanna

Keyword(s):

Degradation Products ◽

Sodium Hydroxide Solution ◽

Hplc Method ◽

Stress Conditions ◽

Forced Degradation ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Successful Separation ◽

Forced Degradation Studies

This paper describes the development of reverse phase HPLC method for etoricoxib in the presence of impurities and degradation products generated from the forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of etoricoxib was observed under base and oxidation environment. The drug was found stable in other stress conditions studied. Successful separation of the drug from the process related impurities and degradation products were achieved on zorbax SB CN (250 x 4.6 mm) 5 μm particle size column using reverse phase HPLC method. The isocratic method employed with a mixture of buffer and acetonitrile in a ratio of 60:40 respectively. Disodium hydrogen orthophosphate (0.02 M) is used as buffer and pH adjusted to 7.20 with 1 N sodium hydroxide solution. The HPLC method was developed and validated with respect to linearity, accuracy, precision, specificity and ruggedness.

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Quantification of Pimavanserin in Bulk and Tablet Dosage Form Using A Stability Indicating High Performance Liquid Chromatographic Method

Pharmaceutical Sciences ◽

10.15171/ps.2018.42 ◽

2018 ◽

Vol 24 (4) ◽

pp. 291-297 ◽

Cited By ~ 1

Author(s):

Geetha Bhavani Koduri ◽

Hari Babu Bollikolla ◽

Ramachandran Dittakavi ◽

Srinivasu Navuluri

Keyword(s):

High Performance ◽

Dosage Form ◽

Degradation Products ◽

Antipsychotic Agent ◽

Hplc Method ◽

Array Detector ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Stability Indicating ◽

Tablet Dosage

Background: Pimavanserin, an antipsychotic agent, is used to treat patients suffering with Parkinson's disease. Till now no stability indicating reverse phase HPLC method was reported for the quantification of pimavanserin in bulk and tablet dosage form. Hence in the present study, a new sensitive, precise and accurate stability indicating reverse phase HPLC method with photodiode array detector has been developed for the quantification of pimavanserin in bulk and tablet dosage form. Methods: Separation and analysis of pimavanserin was achieved on Kromasil C18 (5 µm, 250 mm × 4.6 mm) column using 0.1M NaH2PO4, methanol and acetonitrile in ratio of 55:30:15 (v/v/v) as mobile phase at 25°C. The flow rate was 1.0 ml/min. The effluents were monitored with detector set at 239 nm. The method validation was done with regard to the guidelines by the International Conference on Harmonization. Pimavanserin was subjected to acid, alkali and neutral hydrolysis, hydrogen peroxide oxidation, thermal degradation, and photo (sunlight) degradation. Results: Linear relationship was obtained between the concentration of drug and peak area response in the range of 4.25-34.0 µg/ml. The limits of detection and quantitation were found to be 0.027 µg/ml and 0.089 µg/ml, respectively. All the validation characteristics were within the acceptance criteria. The peaks of degradation products were well resolved from the pimavanserin peak. Conclusion: The developed and validated method is able to quantify the pimavanserin in the presence of degradation products.

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Stability Indicating Method to Analyze Benidipine and Chlorthalidone Using HPLC Technique: Establishment, Validation and Application to Tablets

Pharmaceutical Sciences ◽

10.34172/ps.2019.58 ◽

2020 ◽

Vol 26 (1) ◽

pp. 75-81

Author(s):

Kadali Jagadeesh ◽

Nowduri Annapurna

Keyword(s):

Hplc Method ◽

Phase System ◽

Reverse Phase ◽

Degradation Study ◽

Stability Indicating ◽

Stability Indicating Method ◽

Dipotassium Hydrogen Phosphate ◽

Photodiode Array ◽

Tablet Dosage

Background : The combination of chlorthalidone and benidipine was used to manage hypertension. The mixture of chlorthalidone and benidipine in tablet dosage form has not been previously determined by any method. A stability indicating HPLC method was developed for the simultaneous determination of benidipine and chlorthalidone in bulk and tablets. Methods: Chromatographic separation was accomplished in a reverse phase system using an isocratic elution with a mobile phase composed of methanol-0.1M dipotassium hydrogen phosphate buffer (40:60, v/v), at 1 ml/min flow rate. The photodiode array (PDA) detector set at 260 nm was used to detect and quantify benidipine and chlorthalidone. Benidipine and chlorthalidone tablet samples were subjected to degradation under acid, neutral, alkali, thermal, photo and oxidative. The proposed method was effectively adapted to quantify benidipine and chlorthalidone in the combined tablet formulation. Results: The elution times for benidipine and chlorthalidone were approximately 4.573 min and 6.422 min, respectively. The method was validated within a concentration range of 2 - 6 μg/ml (R2 = 0.9997) for benidipine and 6.25 - 18.75 μg/ml (R2 = 0.9998) for chlorthalidone. Adequate results were obtained for precision (RSD% = 0.106% for benidipine and RSD% = 0.031% for chlorthalidone) and accuracy (99.95 - 100.25 % mean recovery for benidipine and 99.60 - 99.63% mean recovery for chlorthalidone). Robustness has also been found to be acceptable. During the degradation study, interference was not noticed in the analysis of studied drugs. Conclusion: The findings demonstrated that the method could be useful for determination of the selected drug combination in routine analysis.

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