scholarly journals ESTIMATION OF AMLODIPINE BESYLATE AND IRBESARTAN IN PHARMACEUTICAL FORMULATION BY RP-HPLC WITH FORCED DEGRADATION STUDIES

2019 ◽  
pp. 159-167 ◽  
Author(s):  
T Hemant Kumar ◽  
CH. ASHA ◽  
D. GOWRI SANKAR
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Forced Degradation ◽  
Amlodipine Besylate ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Liquid Chromatographic

Objective: To develop and validate a simple, specific, accurate, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method with forced degradation studies for the simultaneous estimation of amlodipine besylate and irbesartan in the pharmaceutical formulation. Methods: The chromatographic separation of the two drugs were achieved using Enable C 18G column (250 ×4.6 mm; 5 µm) in isocratic mode with mobile phase consisting of sodium acetate buffer (pH 4.0) and acetonitrile (30:70, % v/v) with a flow rate of 0.6 ml/min. Ultraviolet(UV) detection was carried out at 238 nm. The proposed method was validated for linearity, range, accuracy, precision, robustness, limit of detection (LOD) and limit of quantification (LOQ). The tablet formulation was subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis. Results: The retention time for amlodipine besylate and irbesartan were found to be 5.512 and 6.321 min respectively. Linearity was observed over a concentration range 4-32 µg/ml for amlodipine besylate (r2 =0.9999) and 10-70 µg/ml for Irbesartan (r2 =0.9998). The % relative standard deviation (RSD) for Intraday and Interday precision was found to be 0.436 and 0.699 for amlodipine besylate and 0.435 and 0.30 for irbesartan. Amlodipine besylate shown stability towards acidic and thermal whereas in basic, oxidative and photolytic it shown less stability in which it degraded to more extent. Irbesartan shown stability towards thermal conditions whereas in remaining conditions it degrades to more extent especially in oxidative conditions. Conclusion: The developed reverse phase high performance liquid chromatographic (RP-HPLC) method was also found to be simple, precise and sensitive for the simultaneous determination of amlodipine besylate and irbesartan in the tablet dosage form.

scholarly journals RP-HPLC Method development, Validation and Forced Degradation for Simultaneous estimation of Benserazide HCl and Levodopa in a Marketed Formulation

2020 ◽  
Vol 13 (3) ◽  
pp. 206-216
Author(s):  
Madhusudan Bhoir ◽  
Nutan Rao
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Uv Detector ◽  
Column Temperature ◽  
Rp Hplc ◽  
Liquid Chromatographic

The objective of the study was to develop and validate a novel, stability indicating, simple, rapid, accurate, precise and isocratic reverse-phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of benserazide HCl and levodopa in a marketed formulation. Chromatographic separation was achieved by using C18 Cosmosil 4.6 × 250 mm column with a mixture of phosphate buffer pH 2 and acetonitrile in proportion of 95:5 as mobile phase at a flow rate of 1.0 ml/min and column temperature 25°C. The detection was carried out at 210 nm using UV detector. The retention time for benserazide and levodopa was found to be 3.1 minutes and 6.6 minutes respectively and recoveries from tablet were between 98 and 102 %.

scholarly journals METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CURCUMIN AND PIPERINE BY RP-HPLC

2019 ◽  
Vol 11 (1) ◽  
pp. 216 ◽  
Author(s):  
Ramya Kuber B.
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Reverse Phase ◽  
Limit Of Quantification ◽  
Average Percentage ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: To develop a simple, sensitive, specific, accurate reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of curcumin and piperine.Methods: The separation was done using a column Inertsil–ODS C18 (250 mm × 4.6 mm, 5µ particle size) and mobile phase composed of methanol: water (45:55 v/v), flow rate at 1 ml/min and detection was carried out at 282 nm with photodiode array (PDA) detector.Results: The separation of curcumin and piperine were found to be at the retention time of 2.433 min and 3.095 min, respectively. The method was found to be linear at a concentration range 20-80 µg/ml for curcumin and piperine. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.05µg/ml and 0.17µg/ml for curcumin and 0.18µg/ml and 0.53µg/ml for piperine respectively. The average percentage recoveries of curcumin and piperine were in the range of 98-100.6%.Conclusion: A simple and sensitive reverse phase high performance liquid chromatographic method was developed for the estimation of curcumin and piperine.

A simple derivatization RP-HPLC method for the simultaneous determination of zineb and hexaconazole in pesticide formulation using a PDA detector

2021 ◽  
Author(s):  
Vilas K. Patil ◽  
Nilesh D. Dhande ◽  
Narendra H. Petha ◽  
Hemant P. Narkhede
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Pesticide Formulation ◽  
Liquid Chromatographic

A simple derivatization reverse-phase high performance liquid chromatographic method for the simultaneous analysis (separation and quantification) of zineb and hexaconazole has been optimized and validated.

scholarly journals VALIDATED RP-HPLC METHOD AND UNIQUE MOBILE PHASE FOR THE SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND VALSARTAN FROM SOLID DOSAGE FORM AND ROSUVASTATIN AND VALSARTAN FROM BULK

2019 ◽  
pp. 156-162
Author(s):  
DYADE GK ◽  
SAWANT RL
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of amlodipine besylate (AD) and valsartan (VAL) in pharmaceutical dosage form, and rosuvastatin (RV) and VAL from the bulk mixture. Method: Chromatographic separation was performed on RP-C18 column. The optimized unique mobile phase (acetonitrile:water and pH adjusted to 4.8 with acetic acid) was pumped at a flow rate of 0.8 ml/min in the ratio of 75:25% v/v, and the eluents were monitored at 245 nm. Results: The assay was performed with tablet and percentage of assay was found to 101.39 for AD and 100.05 for VAL, respectively, and with bulk mixture, percentage of assay was found to 99.58 for RV and 100.32 for VAL, respectively. Linearity was obtained in the concentration range of 1–12 μg/ml for AD, 5–50 μg/mL for VAL, and 2–20 μg/ml for RV. The method was statistically validated and RSD was found to be <2%, indicating high degree of accuracy and precision of the proposed RP-HPLC method. Conclusions: The method suggests usefulness of unique mobile phase during the estimation of two or more multicomponent dosage forms. Due to its simplicity, rapidness, high precision, and accuracy, the proposed RP-HPLC method can be applied for simultaneous determination of AD and VAL in pharmaceutical dosage form, and RV and VAL in bulk mixture.

scholarly journals Development and Validation of Estimation of Genotoxic Impurity (Benzimidamidecontent) in Leflunomide by Using RP-HPLC Technique

2021 ◽  
pp. 78-85
Author(s):  
Mohan Bhatale ◽  
Neelakandan Kaliyaperumal ◽  
Gopalakrishnan Mannathusamy ◽  
Gurunathan Ramalingam
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Reverse Phase ◽  
Intermediate Precision ◽  
Rp Hplc ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Program Mode

The measurement of Genotoxic contaminant, a simple, selective, linear, accurate, and specific reverse phase high-performance liquid chromatographic (RP-HPLC) process was proposed. A Benzimidamide impurity in the medication Leflunomide has been discovered. Separation and analysis were carried out on Zorbax SB phenyl (4.6 mm x 250 mm) with a particle size of 5.0 μm. with 0.1 % Triethylamine in purified water with a pH of 7.0 and a buffer of phosphoric acid (20% in water). The mobile phase is a 40:60 mixture of buffer and Acetonitrile with degassing. Isocratic program mode was used. The elution was carried out at a rate of 1.0 mL/min with UV detection at a wavelength of 289 nm. The temperature of the selected column oven is 25°C. The linearity and accuracy of Benzimidamide are covered in this approach, with a LOQ limit of 150 percent (i.e.0.03 to 0.45 ppm). The observed correlation coefficient is 0.99994, with a range of 100.01 to 104.8 for recovery. The measured percent RSD of six spiked test preparation is below 5.0 percent in procedure precision (i.e. repeatability) and intermediate precision (IP). When maintained at room temperature, the standard and sample remained stable for three days. System appropriateness characteristics such as tailing factor and percent RSD do not exhibit significant changes in robustness experiments. For the detection of Benzimidamide the present RP-HPLC method is act as selective, robust, linear and precise.

QBD ASSISTED RP-HPLC METHOD FOR IDENTIFICATION OF TERAZOSIN IN BULK DRUG AND PHARMACEUTICAL SAMPLE

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (03) ◽  
pp. 19-26
Author(s):  
C. Dhal ◽  
◽  
D. Rajput ◽  
V. Tiwari ◽  
A. Teotia ◽  
...  
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Forced Degradation ◽  
Pharmaceutical Drugs ◽  
Reliable Technique ◽  
Rp Hplc ◽  
Bulk Drug ◽  
Liquid Chromatographic

Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) proves to be a convenient and reliable technique for the identification of various compounds, such as pharmaceutical drugs of chemical as well as phyto origin, food compounds and others. Analytical method for the estimation of alpha-1 antagonist terazosin, a potent anti-hypertensive agent for enlarged prostate, was developed, optimized for the best fit condition using statistical software Minitab and validated as per International Conference on Harmonization (ICH) Q2 (R1) guidelines. Partitioning of the desired molecule was achieved on Agilent Zorbax C18 column with dimensions of 250 mm X 4.6 mm and a particle size 5μm against mobile phase containing acetate buffer adjusted to pH 6.0 and acetonitrile (ACN) in a ratio 30:70 (V/V), run isocratically for sufficient time. The linear model was established between 50 – 250 ppm with a regression coefficient (r2) of 0.9971 and with detection (LOD) and quantification limit (LOQ) of 17.754 ppm and 53.802 ppm, respectively. The method was precise, accurate, robust and able to distinguish between the adduct generated during forced degradation studies.

Development and Validation of RP-HPLC method for the Estimation of Ritonavir in API and tablet Formulation

2021 ◽  
pp. 5457-5460
Author(s):  
Avinash Birajdar ◽  
Varsha Tegeli ◽  
Suyash Ingale ◽  
Gajanand Nangare
Keyword(s):  
High Performance ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

A Reverse Phase High Performance Liquid Chromatographic method has been developed and validated for estimation of Ritonavir in API and Tablet formulation. The chromatographic separation was carried out using ZOROBAX Bonus-RP C-18 column (250 x 4.6mm, 5µm) as stationary phase and Methanol: Acetonitrile: 0.1% Trifluoroacetic acid water (81:9:10) as mobile phase at 1.0 ml/min flow rate and detection was carried out at 250 nm. The method was validated accordance to the Guidelines of International Council for Harmonization (ICH). Ritonavir have linearity in the concentration range of 50-150µg/ml with correlation coefficient (r2=1) respectively. Ritonavir eluted at 3.05 min respectively. The method is sensitive, precise and accurate. So, the method can be successfully applied for the routine analysis of Ritonavir in pharmaceutical formulations.

scholarly journals Improvement of Development and Validation of an RP-HPLC Method for The Fluvastatin Sodium Using QbD Approach and Its Application to Forced Degradation Studies

2020 ◽  
Vol 11 (4) ◽  
pp. 6938-6948
Author(s):  
Dhamdhere Rupali Balasaheb ◽  
Vijayalakshmi A
Keyword(s):  
High Performance ◽  
Hplc Method ◽  
Forced Degradation ◽  
Reverse Phase ◽  
Test Configuration ◽  
Rp Hplc ◽  
Maintenance Time ◽  
Forced Degradation Studies ◽  
Connection Coefficient ◽  
Development And Validation

The current examination portrays the improvement of the QbD way to deal with Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) framework utilizing Design of Experiments.Each of the three principle parts of the RP-HPLC measure (Buffer pH, Organic Step-percent acetonitrile, Organic Modifier-Methanol) are introduced in a successful test configuration zeroed in on methodical exploring. Through measurable investigation devices, for example, Analysis of Variance (ANOVA) and plots that uncovered the last chromatographic states of the strategy, the criticalness and communication impacts of these boundaries on the reaction factors (maintenance time and following component) were assessed. The chromatographic detachment was accomplished on Thermo Hypersil BDS RP C18 (250 × 4.6 mm, 5μ) section utilizing Buffer (pH 6.8): Acetonitrile (60:40v/v) as portable stage and discovery was finished utilizing Photo-Diode Array (PDA) identifier at 288 nm. The created fluvastatin sodium technique is direct with coefficients of relationship over a scope of 10-80μg/ml. The (R2) estimation of the connection coefficient is 0.999. The percent RSD for the strategy's exactness and accuracy was discovered to be under 2 percent. Investigations of Forced Degradation uncovered that the method was found to show security. The outcomes indicated that the strategy proposed is proper for the exact and precise assurance and detailing of fluvastatin sodium in mass.

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