scholarly journals BIOANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CLOPIDOGREL BISULFATE IN WISTAR RAT PLASMA AND ITS APPLICATION TO PHARMACOKINETIC STUDY

2022 ◽  
pp. 106-111
Author(s):  
RAMYA SRI SURA ◽  
SUBRAHMANYAM CVS ◽  
SHYAM SUNDER RACHAMALLA
Keyword(s):  
Method Development ◽  
Wistar Rat ◽  
Rat Plasma ◽  
Hplc Method ◽  
Clopidogrel Bisulfate ◽  
Ich Guidelines ◽  
Chromatographic Condition ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

Objective: A novel, simple, precise, accurate, sensitive, and reproducible HPLC method for determining clopidogrel bisulfate in Wistar rat plasma was developed and validated. Methods: The chromatographic separation was performed using Xterra C18 (250 x 4.6 mm, 5μ) column. Mobile phase composed of Acetonitrile ACN: 0.05M potassium dihydrogen orthophosphate buffer pH 4.2 and in the ratio of 75:25% v/v at a flow rate of 1.2 ml/min. Detection was carried out using a PDA detector at 220 nm. The bioanalytical clopidogrel method was validated as per ICH guidelines. Results: The selected chromatographic condition was found to efficiently separate clopidogrel bisulfate (RT-2.838 min). The calibration curve was linear over the concentration range 40-200 ng/ml in Wistar rat plasma with a correlation coefficient of 0.999, respectively. The precision study revealed that the cumulative percentage variation was within the acceptable limit, and accuracy research showed the value of mean percent recovery between 99.72-99.83 %. Conclusion: A simple, rapid, specific, accurate, and precise analytical method was developed and validated using Wistar rat plasma. The technique was strictly validated according to the ICH guidelines. Acquired results demonstrate that the proposed strategy can be effortlessly and advantageously applied for routine analysis of clopidogrel in the Wistar rat plasma.

scholarly journals RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

scholarly journals Determination of Chromones in Dysophylla stellata by HPLC: Method Development, Validation and Comparison of Different Extraction Methods

2010 ◽  
Vol 5 (4) ◽  
pp. 1934578X1000500 ◽  
Author(s):  
Raju Gautam ◽  
Amit Srivastava ◽  
Sanjay M. Jachak
Keyword(s):  
Method Development ◽  
Gradient Elution ◽  
Extraction Methods ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Efficient Extraction ◽  
Hplc Method Development ◽  
Development And Validation

An HPLC method with reflux as an efficient extraction method has been developed for quantification of chromones in Dysophylla stellata Benth. Separation was achieved on a C18 column with a mobile phase of 0.5% (v/v) acetic acid in water (A), and ACN (B) under gradient elution at 1 mL/min. Chromones (1 and 2) isolated from D. stellata were used as standards for method development and validation was achieved according to ICH guidelines. Extracts prepared by three different methods [reflux, ultrasonication and accelerated solvent extraction (ASE)] were used for analysis by the validated method. The proposed HPLC method is simple, accurate and selective for the separation and quantification of chromones in D. stellata.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous estimation of ceftriaxone and tazobactum in sterile powder for injection

2019 ◽  
Vol 1 (2) ◽  
pp. 40-43
Author(s):  
T. Vimalakkannan ◽  
P. Shaik Parveen ◽  
Salomi ◽  
K. Ravindra Reddy
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Accurate Method ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

A simple, rapid, precise and accurate method is developed for the quantitative simultaneous determination of ceftriaxone and tazobactum in bulk and pharmaceutical formulations. Separation of ceftriaxone and tazobactum was successfully achieved by using Inertsil C18 ODS column 250X4.6mm, 5µm in an isocratic mode using water and acetonitrile (80:20) at a flow rate of 1.0 ml/min and was monitored at 254 nm with a retention time of 3.049 minutes and 4.317 minutes for ceftriaxone and tazobactum respectively. The method was validated and the response was found to be linear in the drug concentration range of 20µg/ml to 80 µg/ml for ceftriaxone and 5 µg/ml to 35 µg/ml for tazobactum. The values of the correlation coefficient were found to be 0.999 for ceftriaxone and 0.999 for tazobactum respectively. The LOD and LOQ for ceftriaxone were found to be 0.021 and 0.064 respectively. The LOD and LOQ for tazobactum were found to be 0.030 and 0.091 respectively. The percentage recovery for ceftriaxone and tazobactum were found to be 98-102% respectively which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.  Stability of the drugs was determined by using acid/base, thermal, oxidative stress testing.

RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF LURASIDONE HYHROCHLORIDE IN BULK AND TABLET FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 28-34
Author(s):  
K. Vijaya Sri ◽  
M. Shiva Kumar ◽  
A. Sravani ◽  
Keyword(s):  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Tablet Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

The RP-HPLC were developed and validated for the estimation of lurasidone HCl as per ICH guidelines. A simple, fast, accurate and precise RP-HPLC method was developed by using methanol: water containing 0.01% ortho phosphoric acid in the ratio of 70:30 (V/V). The method was developed in Eclipse C18 column (100 mm × 4.6 mm, 3.5 μm particle size). The method was found to be linear in the range of 2.5- 15µg/mL with a correlation coefficient value of 0.999. The accuracy studies of RP-HPLC method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 100.1-100.6% .The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.30-0.92. Satisfactory validation was also obtained from recovery (99.8%) studies, intra-day and interday precision and robustness 2%. The proposed method was found to be accurate, precise and rapid for the analysis of lurasidone.

RP-HPLC Method Development and Validation For Simultaneous Estimation of Paracetamol and Mefenamic Acid in Pharmaceutical Suspension

2019 ◽  
Vol 10 (04) ◽  
pp. 583-587
Author(s):  
Venkata Nanda Kumar Kopparapu ◽  
Poornima Kasula ◽  
Ajay Kumar Reddy Ankinapalli ◽  
M Venkateswarlu
Keyword(s):  
Mefenamic Acid ◽  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Inflammatory Conditions ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

Paracetamol (PCT) and Mefenamic acid (MFA), in combination, is recommended widely for the treatment of antipyretic and anti-inflammatory conditions. The present works carry a new simple, rapid, precise, accurate, and sensitized method of high-performance liquid chromatography with UV detection for simultaneous quantification of PCT and MFA. The samples are eluted in isocratic mode using a Phenomenex ODS 3V C18 (4.6mm × 250 mm i.d, with a particle size of 5μm) with the mobile composition of methanol: phosphate buffer pH 7.1 (70:30) delivered at a flow rate of 1ml/min with the detection wavelength of 254 nm. It shows good linearity response in the concentration range of 15-35 μg/mL and 6-14 μg/ml for PCT and MFA with the retention times of 3.0 min and 4.8 min, respectively. The quantities of PCT and MFA in pharmaceutical suspension were found to be 99.01% and 101.02%, respectively. The method was quantitatively evaluated according to ICH guidelines taking into consideration the required parameters, and the results obtained are within acceptable limits. So, the proposed method can be employed in the routine analysis and evaluation of MFA and PCT in both bulk and suspension dosage form.

Simultaneous HPLC Method Development and Validation of Bilastine and Montelukast in Bulk and Formulation

2021 ◽  
pp. 6061-6065
Author(s):  
Ankita Shinde ◽  
G.B. Gajeli ◽  
Sneha Ubale ◽  
Vinod Matole
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Tablet Formulations ◽  
Hplc Method Development ◽  
Development And Validation

A new, simple, rapid, selective, precise and accurate reverse phase high performance liquid chromatography assay has been developed for simultaneous estimation of Bilastine, and Montelukast in tablet formulations. The separation was achieved by using Phenomenax Kinetex XB C-18 column (150 x 4.6mm, 5 .) using mobile phase Methanol: 0.1% TFA water (80:20). Injection volume was 10µl. The flow rate was 1.0mL.min-1 and the separated drugs were detected using UV detector at the wavelength of 270nm. The retention time of Bilastine and Montelukast was noted to be 1.27, and 4.86 respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations containing any one of the above drugs, or a combination, without any alteration in the chromatographic conditions.

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