scholarly journals New Method for the Estimation and Validation of Fostemsavir and Ganciclovir by using RP-HPLC

2021 ◽  
Vol 12 (2) ◽  
pp. 1182-1187
Author(s):  
Srinivasa Rao Surabhi ◽  
Neelu Jain
Keyword(s):  
Room Temperature ◽  
Orthophosphoric Acid ◽  
Isocratic Elution ◽  
Movable Part ◽  
Rp Hplc ◽  
Acceptable Range ◽  
Ich Guidelines ◽  
System Suitability ◽  
Study Results ◽  
Recovery Study

We have evolved a completely unique, reliable HPLC technique for simultaneous quantification of Fostemsavir and Ganciclovir. The chromatographic detachment was attained on an X-Bridge phenyl column (150x4.6mm, 3.5 µ) using isocratic elution with a buffer containing 0.1% OPA and acetonitrile proportion of 50:50 as movable part with a stream of 1 mL/min at room temperature. The maximum absorbance of the drugs was observed at 236 nm. Dissolve 1mL of orthophosphoric acid in 1 lt of HPLC marked water and sieved by using 0.45 µ filter paper, this solution was used as a buffer. 10 min run time was used to separate Fostemsavir and Ganciclovir. Analysis was achieved within 15 min over honest linearity within the concentration range from 6-90 µg/mL of Fostemsavir and 2.5-37.5 µg/mL of Ganciclovir. To check the system suitability parameters, the normal solution was injected six times, from the outcomes, it was concluded that all the outcomes were well under the acceptable range. Precision and recovery study results were well under a suitable range. From this technique, an assay of Fostemsavir and Ganciclovir was performed and the results were well under the acceptable range. Degradation studies were carried out on Fostemsavir and Ganciclovir, with a purity threshold greater than the purity angle in all conditions and within the acceptable range. The above-mentioned technique was validated according to ICH guidelines.

New Validated RP-HPLC Method for Cisplatin and Topotecan in API and Vaccine Form and its Stress Studies

2021 ◽  
Vol 12 (1) ◽  
pp. 808-814
Author(s):  
Subrahmanyam Talari ◽  
Anuradha V ◽  
Komala sai prathyusha A
Keyword(s):  
Room Temperature ◽  
Hplc Method ◽  
Stress Studies ◽  
Rp Hplc ◽  
Acceptable Range ◽  
Ich Guidelines ◽  
System Suitability ◽  
Study Results ◽  
Recovery Study ◽  
Hplc Grade Water

We have developed a completely unique and reliable HPLC technique for simultaneous quantification of Cisplatin and Topotecan. A chromatographic detachment was attained on a XDB C18 column (150x4.6mm, 3.5 µ) using isocratic elution with a buffer containing buffer and acetonitrile with the proportion of 60:40 as a movable phase with a flow of 1 mL/min at room temperature and UV detection was carried out at 262 nm. Dissolve 1mL of triethylamine in 1 lt of HPLC grade water and filter through 0.45 µ filter paper. This solution was used as a buffer. 10 min run time was used to separate Cisplatin and Topotecan. The analysis was achieved within 15 min over honest linearity within the concentration range from 5-75 µg/mL of Cisplatin and 2-30 µg/mL of Topotecan. By injecting the standard six times, system suitability parameters were studied and the outcomes were under the acceptable limit. Precision and recovery study results were found to be within a suitable limit. By using the above technique, the assay of the marketed formulation was performed and found to be within the limit. Degradation studies were carried out on Cisplatin and Topotecan, with a purity threshold greater than the purity angle in all conditions and within the acceptable range. The above-mentioned technique was validated according to ICH guidelines.

scholarly journals Stability Indicative and Cost Effective Creation and Validation of Analytical Method of Lopinavir and Rilpivirine by High Performance Liquid Chromatography

2021 ◽  
Vol 12 (1) ◽  
pp. 786-792
Author(s):  
Srinivas L ◽  
Neelu Jain
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Cost Effective ◽  
Ich Guidelines ◽  
System Suitability ◽  
Study Results ◽  
Allowable Range ◽  
Recovery Study ◽  
Hplc Grade Water ◽  
Validation Of Analytical Method

We have developed a completely unique and reliable HPLC technique for simultaneous quantification of Lopinavir and Rilpivirine. Chromatographic detachment was attained on a X-bridge phenyl column (150x4.6mm, 3.5 µ) using isocratic elution with a buffer containing buffer and acetonitrile with the proportion of 70:30 as movable phase with a flow of 1 ml/min at room temperature and UV detection was carried out at 250 nm. Dissolve 1ml of tri ethylamine in 1 lt of HPLC grade water and filter through 0.45 µ filter paper, this solution was used as buffer. 8 min. run time was used to separate Lopinavir and Rilpivirine. Analysis was achieved within 15 min over an honest linearity within the concentration range from 20-300 µg/ml of Lopinavir and 2.5-37.5 µg/ml of Rilpivirine. By injecting the standard six times, system suitability parameters were studied and the outcomes were under the acceptable limit. Precision and recovery study results were found to be within the suitable limit. By using the above technique, assay of Lopinavir and Rilpivirine was performed and found to be within the limit. Degradation studies were carried out on Lopinavir and Rilpivirine, with a purity threshold greater than purity angle in all conditions and within the allowable range. The above mentioned technique was validated according to ICH guidelines.

scholarly journals Validated stability indicating RP-HPLC method for the determination of dolutegravir and rilpivirine in bulk and pharmaceutical dosage forms

2021 ◽  
Vol 12 (3) ◽  
pp. 1961-1966
Author(s):  
Gopinath K ◽  
Padmavathi K. V. ◽  
Murali Krishna N ◽  
Subbarao M
Keyword(s):  
Drug Testing ◽  
Orthophosphoric Acid ◽  
Hplc Method ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Acceptable Range ◽  
Ich Guidelines ◽  
Ethyl Amine

For simultaneous analysis of Dolutegravir and Rilpivirine utilizing RP-HPLC, an accurate, rapid, economical, quick and reliable assay technique was developed and tested. Successful chromatographic detachment using acetonitrile and 0.1 percent tri ethyl amine in the water of pH-2.5 adjusted with 0.1% orthophosphoric acid in 40:60 v/v as a movable phase with a flow of 1 ml/min and UV observation at 230 nm. Chromatography at ambient temperature was performed isocratically, and the run time was 10 min. By injecting the norm six times, device suitability parameters were studied and the findings were far below the acceptance criteria. The linearity analysis was performed at levels ranging from 10% to 150% and the R2 value was found to be 0.999. Precision has been found to be 0.8 for repeatability and 1.2 for intermediate precision. Assay of the commercialized formulation was performed by using the above method, and we get 100.01 percent was present. For routine analysis in drug testing, this chromatographic approach can be effectively implemented. By using the above technique, an assay of the marketed formulation was performed and found to be within the limit. Degradation studies were carried out on Dolutegravir and Rilpivirine, with a purity threshold greater than purity angle in all conditions and within the acceptable range. The above-mentioned technique was validated according to ICH guidelines. 

scholarly journals Stability Indicating Validated HPLC Method for the Determination of Aceclofenac and Misoprostol in Bulk and Pharmaceutical Formulation

2020 ◽  
Vol 11 (4) ◽  
pp. 7848-7853
Author(s):  
Syed Rafi ◽  
Kantipudi Rambabu
Keyword(s):  
Room Temperature ◽  
Orthophosphoric Acid ◽  
Pharmaceutical Preparation ◽  
Hplc Method ◽  
Alkaline Peroxide ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Simultaneous Evaluation ◽  
Formulation Analysis

For the simultaneous evaluation of Aceclofenac and Misoprostol using RP-HPLC, an accurate, rapid, economical, and straightforward, reliable assay technique was developed and demonstrated. The proposed method achieved effective chromatographic separation by using an inertsil ODS column (150mmx4.6mm, 3.5), acetonitrile, and 0.1 percent orthophosphoric acid (OPA) (50:50 v/v) as a mobile phase with a flow rate of 1 ml/min and a wavelength of 227 nm. The retention time (Rt) of Aceclofenac was 3.189 minutes and Misoprostol was 6.966 minutes. Chromatography was performed isocratically at room temperature with a run time of around 10 minutes. The suitability parameters of the system were investigated by multiplying the quality six times, and the results were well within acceptable limits. The linearity analysis was conducted at 10 percent to 150 percent stages, with a regression coefficient of 0.999. Aceclofenac and Misoprostol had LOD and LOQ values of 0.063 ug/ml, 0.063 g/ml, and 0.208 ug/ml and 0.208 g/ml, respectively. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. As a result, it was obvious that the proposed approach was ideal for routine pharmaceutical preparation review and quality control. Validation results were very close to the appropriate maximum. RSD values of less than 2.0 percent indicate that this approach is accurate and precise. The above method was used to perform a retail formulation assay, which showed that 100.24 percent of the formulation was present. Degradation stress conditions in acidic, alkaline, peroxide, and thermal media were investigated. Under ideal conditions, the established method provided efficient, precise, and accurate results. According to ICH guidelines, the approach was justified.

scholarly journals Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

2017 ◽  
Vol 2 (03) ◽  
pp. 41-45
Author(s):  
Sireesha D ◽  
Sai Lakshmi E ◽  
Sravya E ◽  
Vasudha Bakshi
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Room Temperature ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Isocratic Mode

A new simple, rapid, specific, accurate, precise and novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the estimation of Sitagliptin Phosphate in the pharmaceutical dosage form. The chromatographic separation for Sitagliptin was achieved with mobile phase containing methanol, Thermoscientific C18 column, (250x4.6 particle size of 5μ) at room temperature and UV detection at 248 nm. The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Sitagliptin was 1.91min. The above method was validated in terms of linearity, accuracy, precision, LOD and LOQ in accordance with ICH guidelines.

scholarly journals Development and Validation of Stability-Indicating HPLC Methods for the Estimation of Lomefloxacin and Balofloxacin Oxidation Process under ACVA, H2O2, or KMnO4 Treatment. Kinetic Evaluation and Identification of Degradation Products by Mass Spectrometry

Molecules ◽  
2020 ◽  
Vol 25 (22) ◽  
pp. 5251
Author(s):  
Barbara Żuromska-Witek ◽  
Paweł Żmudzki ◽  
Marek Szlósarczyk ◽  
Anna Maślanka ◽  
Urszula Hubicka
Keyword(s):  
Room Temperature ◽  
Oxidation Process ◽  
Degradation Products ◽  
Isocratic Elution ◽  
Kinetic Evaluation ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Azo Initiator ◽  
Development And Validation ◽  
Kinetics Of

The oxidation of lomefloxacin (LOM) and balofloxacin (BAL) under the influence of azo initiator of radical reactions of 4,4′-azobis(4-cyanopentanoic acid) (ACVA) and H2O2 was examined. Oxidation using H2O2 was performed at room temperature while using ACVA at temperatures: 40, 50, 60 °C. Additionally, the oxidation process of BAL under the influence of KMnO4 in an acidic medium was investigated. New stability-indicating HPLC methods were developed in order to evaluate the oxidation process. Chromatographic analysis was carried out using the Kinetex 5u XB—C18 100A column, Phenomenex (Torrance, CA, USA) (250 × 4.6 mm, 5 μm particle size, core shell type). The chromatographic separation was achieved while using isocratic elution and a mobile phase with the composition of 0.05 M phosphate buffer (pH = 3.20 adjusted with o-phosphoric acid) and acetonitrile (87:13 v/v for LOM; 80:20 v/v for BAL). The column was maintained at 30 °C. The methods were validated according to the ICH guidelines, and it was found that they met the acceptance criteria. An oxidation process followed kinetics of the second order reaction. The most probable structures of LOM and BAL degradation products formed were assigned by the UHPLC/MS/MS method.

scholarly journals Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form

2020 ◽  
Vol 1 (4) ◽  
pp. 95-100
Author(s):  
Sonalika Patro ◽  
S. Harshith Kumar ◽  
M. Barath kumar ◽  
E. Masthaniah ◽  
K. Sairam ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Precision Study ◽  
Tablet Dosage

A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of  1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.

scholarly journals Stability indicating RP-HPLC method development for docetaxel trihydrate

2019 ◽  
Vol 9 (4-s) ◽  
pp. 525-528 ◽  
Author(s):  
Nilesh R. Rarokar ◽  
Pramod B. Khedekar
Keyword(s):  
Room Temperature ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
System Suitability ◽  
Steel Column ◽  
Stainless Steel Column ◽  
Bulk Drug ◽  
Hplc Method Development

The purpose of present study was to develop RP-HPLC method for estimation of docetaxel trihydrate which should be a suitable, simple, precise, accurate, robust, and reproducible. The samples were assayed by the Shimadzu HPLC instrument - LC-20AD (Japan) equipped with Shimadzu SPD-M20A UV-VIS detector operated at wavelength of 230 nm. The binary gradiant pump was used for the analytical method development. The reverse phase stainless steel column (150 × 4.6 mm) packed with 5 μm particles (C-8, LiCrosphore® 100, Germany) was used to take chromatograph. A mobile phase consisting of acetonitrile/phosphate buffer 20 mM, (45:55, v/v), pH 3.5 adjusted with o-phosphoric acid at a flow rate of 1 mL/min. The method was validated by system suitability and reproducibility. The linearity was also determined using samples with five different concentrations of 20, 40, 60, 80 and 100 µg/mL. The results of the study showed that the developed RP-HPLC method is simple and robust which is useful for the estimation of docetaxel trihydrate in bulk drug and in pharmaceutical dosage form. The results of stability show that the method has stability over a period of 48 h at room temperature. Keyword: Docetxel trihydrate, RP-HPLC method, validation, stability

scholarly journals Method Development and Validation of RP-HPLC Method for the Estimation of Ormeloxifene

2017 ◽  
Vol 2 (03) ◽  
pp. 78-82
Author(s):  
Anusha Shivaraj ◽  
Shireesha Battula
Keyword(s):  
Mobile Phase ◽  
Room Temperature ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Isocratic Mode ◽  
Ich Guideline

A new simple, specific, accurate, precise RP-HPLC method has been developed for the estimation of Ormeloxifene. The chromatographic separation for Ormeloxifene was achieved with mobile phase containing methanol :ACN(70:30 v/v), agilent C18 column (4.6 x150 mm) 5 μ at room temperature and UV detection at 274nm.The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Ormeloxifene was found to be 2.497min. The method was validated according to ICH guideline for linearity, specificity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines.

DEVELOPMENT AND VALIDATION OF RP-HPL C METHOD FOR THE ESTIMATION OF ASCORBIC ACID IN HEALTH DRINKS

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 43-47
Author(s):  
N. Mallikarjuna Rao ◽  
◽  
D. Gowri Sankar
Keyword(s):  
Particle Size ◽  
Ascorbic Acid ◽  
Acetic Acid ◽  
Mobile Phase ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Development And Validation

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of ascorbic acid in health drinks. Isocratic elution at a flow rate of 0.9mL/min was employed on a symmetry C18 column (250x4.6mm, 0.5μ in particle size) at ambient temperature. The mobile phase consisted of water with acetic acid: methanol 95:5% (V/V). The UV detection wavelength was 245 nm and 20μL sample was injected. The retention time for ascorbic acid was 4.61± 0.22 min. The percentage RSD for precision and accuracy of the method was found to be less than the method which was validated as per the ICH guidelines. The method was successfully applied for routine analysis of ascorbic acid in health drinks.

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