scholarly journals Exploring RP-HPLC Method for analysis of Axitinib in Bulk and in-house Tablets

1970 ◽  
Vol 6 (2) ◽  
pp. 135-141
Author(s):  
Shailesh S Chalikwar ◽  
Satish D Kayande ◽  
Inderbir Singh ◽  
Atul A Shirkhedkar
Keyword(s):  
High Performance ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Array Detector ◽  
Diode Array Detector ◽  
Chromatography Method ◽  
Optimal Flow ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

Axitinib is a tyrosine kinase Inhibiter. In a commenced analysis, a effortless and responsive high-performance liquid-chromatography method was developed and validated for the quantitative estimation of Axitinib in bulk and in-house tablet dosage form. The present method was developed and validated using LC-GC Qualisil BDS C18 (250 mm × 4.6 mm, 5 μm). The separation of Axitinib was employed using a methanol: water 85:15% v/vas a mobile phase at optimal flow rate 1 mL/min and column oven temperature 30°C. While, Axitinib was examined at 330 nm with a photo diode array detector; retention timewas found to be 3.23 min.The intended method was validated by ICH rules for the accuracy, precision, sensitivity, and ruggedness. The linearity was followed in the concentration range of 4 - 24 μg/ mL as demonstrated by correlation coefficient (r2) of 0.9994. The robustness of proposed method was assessed by purposelyvarying the chromatographic conditions. Consequently, the intended method can routinely be subjected for th estimation of Axitinib in bulk and in tablets formulation.

scholarly journals Quantitative Estimation of Sorafenib Tosylate Its Pure Form and in Its Tablet Formulation by RP-HPLC Method

2013 ◽  
Vol 2013 ◽  
pp. 1-3 ◽  
Author(s):  
R. Kalaichelvi ◽  
E. Jayachandran
Keyword(s):  
High Performance ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Pure Form ◽  
Mobile Phase Composition ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Isocratic Mode

A simple, accurate, specific reverse-phase, high-performance liquid chromatography method has been developed for the determination of sorafenib tosylate in its pure form and its tablets. In this method, sorafenib tosylate was eluted by isocratic mode using a Phenomenex Luna C18 column by a mobile phase composition of acetonitrile and water in the ratio of 82.5 : 17.5, v/v. The flow rate was 1.5 mL/min. The eluted drug was monitored at 265 nm and the method was found to be linear from 5 to 80 μg/mL. The method was validated by linearity, precision, accuracy, LOD, and LOQ. The accuracy report denotes that there is not any interference of additives used in the formulation.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF ZOLMITRIPTAN IN BULK DRUG AND TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (08) ◽  
pp. 20-26
Author(s):  
P. K Arora ◽  
◽  
A. Chauhan ◽  
D Duggal ◽  
P. K., Saini ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Hplc Method ◽  
Array Detector ◽  
Calibration Plot ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Elution Method ◽  
Bulk Drug ◽  
Tablet Dosage

A convenient, simple, accurate, precise and reproducible Reverse Phase High Performance Liquid Chromatography method was developed and validated for the estimation of zolmitriptan in the bulk drug and tablet dosage form. Objective was achieved under optimized chromatographic conditions on Dionex UHPLC system with Dionex C18 column (250 × 4.6 mm, 5 mcm particle size) using mobile phase composed of methanol and 0.005 M ammonium acetate in the ratio of 50:50 V/V. The separation was achieved using an isocratic elution method with a flow rate of 1 mL/ min at room temperature. The effluent was monitored at 230 nm using diode array detector. The retention time of zolmitriptan was found to be 3.4 minutes and the standard calibration plot was linear over a concentration range of 10–120 mcg/ mL with r2 = 0.9999. The LOD and the LOQ were found to be 3.7 mcg/ mL and 11.1 mcg/ mL respectively. The amount of zolmitriptan present in the bulk drug was 99.81 % and in the formulation 98.05 % of the stated amount respectively. The method was validated statistically using the %RSD and the values are found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 99.2± 0.5706 %. So, the proposed method was found to be simple, specific, linear, and robust. Hence this method was conveniently and easily applied for routine analysis of zolmitriptan in bulk drug and tablet dosage form.

Assay and Dermatokinetics of Tetrahydrocurcumin Lipidic Nanostructures Using Reverse Phase-High Performance Liquid Chromatography

2021 ◽  
Vol 09 ◽  
Author(s):  
Priyanka Narula ◽  
Komal Saini ◽  
Megha Saini ◽  
Dinesh Singla ◽  
Anurag Singh Chauhan ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Quantitative Estimation ◽  
Healing Process ◽  
Entrapment Efficiency ◽  
Hplc Method ◽  
Reverse Phase ◽  
Chromatography Method ◽  
Rp Hplc

Background: Envisaging the poor solubility (56ng/ml) and permeability of tetrahydrocurcumin (THCC), it was formulated into lipidic nanostructures to enhance its bioavailability upon topical application to promote the healing process for skin inflammatory disorders. Lack of literature on suitable method for determining THCC per se and nanoformulations prompted us to develop a RP-HPLC method to detect the drug in its nanostructures and in pig ear skin post dermatokinetics. Objective: The present investigation aimed to develop a simple, precise and RP-HPLC method for the quantitative estimation of THCC in prepared lipidic nanostructures, its ointment and in skin homogenate obtained post dermatokinetic study. Method: THCC encapsulated nanostructures and ointment were formulated using modified emulsification method and embedded into an ointment base to enhance its spreadability and improve patient compliance. A fast and sensitive reverse phase high performance liquid chromatography method was developed using a Hypersil BDS reverse phase C18 column (4.6 mm × 250 mm, 5 μm) with mobile phase comprising tetrahydrofuran (THF) and 1 mgmL-1 citric acid (4:6), at a flow rate of 1.0 mLmin−1 with a run time of 20 min. Result: THCC nanostructures were successfully prepared using spontaneous microemulsification method. THCC was detected at 282 nm and revealed two peaks which were attributed to the keto-enol tautomerism in the molecule with retention times of 6.23 min and 11.06 min respectively. The assay of THCC in nanostructures and ointment was found to be 98.30% and 99.98% with entrapment efficiency 77.00±2.74 %. The dermatokinetic studies revealed sufficient release of THCC from its ointment up till 24 hr with a concentration of 1382 μgcm-2, for causing a therapeutic effect. Conclusion: The method was found to be reproducible and robust as shown by low coefficient of variation and a constant analyte/IS ratio. It was successfully employed for the estimation of THCC assay in nanostructures and it’s ointment and dermatokinetic analysis in skin.

scholarly journals A NEW REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF SERRATIOPEPTIDASE AND DICLOFENAC SODIUM IN BULK AND TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 150
Author(s):  
Manasi Kulkarni B ◽  
Anagha Joshi M
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Diclofenac Sodium ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The objective is to study the development of a simple, rapid, specific, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of serratiopeptidase (SER) and diclofenac (DC) sodium in bulk and tablet formulation.Methods: RP-HPLC method was developed for the simultaneous estimation of SER and DC sodium in tablet formulation. The separation was achieved by Kromasil C18 column (250 mm × 4.6 mm, 5 μm particle size) with phosphate buffer pH-7 and o-phosphoric acid:methanol:acetonitrile (5:4:1% v/v/v). Flow rate was maintained at 1 mL/min and UV detection was carried at 270 nm.Result: For RP-HPLC method, the retention time for SER and DC sodium was found to be 3.3833 min and 8.1667 min, respectively. The method was validated for accuracy, precision, and specificity. Linearity for SER and DC sodium was in the range of 5–50 μg/ml.Conclusion: The developed RP-HPLC method is simple, accurate, rapid, sensitive, precise, and economic. Hence, this method can be employed successfully for the estimation of SER and DC sodium in both bulk and tablet dosage forms.

scholarly journals A NEW REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF SERRATIOPEPTIDASE AND DICLOFENAC SODIUM IN BULK AND TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 150
Author(s):  
Manasi Kulkarni B ◽  
Anagha Joshi M
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Diclofenac Sodium ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The objective is to study the development of a simple, rapid, specific, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of serratiopeptidase (SER) and diclofenac (DC) sodium in bulk and tablet formulation.Methods: RP-HPLC method was developed for the simultaneous estimation of SER and DC sodium in tablet formulation. The separation was achieved by Kromasil C18 column (250 mm × 4.6 mm, 5 μm particle size) with phosphate buffer pH-7 and o-phosphoric acid:methanol:acetonitrile (5:4:1% v/v/v). Flow rate was maintained at 1 mL/min and UV detection was carried at 270 nm.Result: For RP-HPLC method, the retention time for SER and DC sodium was found to be 3.3833 min and 8.1667 min, respectively. The method was validated for accuracy, precision, and specificity. Linearity for SER and DC sodium was in the range of 5–50 μg/ml.Conclusion: The developed RP-HPLC method is simple, accurate, rapid, sensitive, precise, and economic. Hence, this method can be employed successfully for the estimation of SER and DC sodium in both bulk and tablet dosage forms.

scholarly journals STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DOSULEPIN HYDROCHLORIDE AND METHYLCOBALAMIN IN TABLET DOSAGE FORM

2017 ◽  
Vol 9 (4) ◽  
pp. 69 ◽  
Author(s):  
Radhika Shah ◽  
Ragin Shah
Keyword(s):  
Dosage Form ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Stress Degradation ◽  
Pharmaceutical Industries ◽  
Tablet Dosage

Objective: To develop an accurate, simple, rapid, precise, economic and stability indicating RP-HPLC method for the simultaneous estimation of dosulepin hydrochloride and methylcobalamin in tablet dosage form and validate as per ICH guidelines.Methods: The column used was Kromasil C18 (250 X 4.6 mm, 5 µm), with a mobile phase containing acetonitrile: phosphate buffer pH 3 adjusted with o-phosphoric acid (60:40) with a flow rate of 1 ml/min. The effluents obtained were monitored at 285 nm with photodiode array detector. Dosulepin hydrochloride and methylcobalamin were subjected to stress degradation conditions like hydrolysis (acid and base), oxidation, thermal and photolysis degradation. The samples subjected to stress degradation were analysed by the developed method.Results: The retention time for dosulepin hydrochloride and methylcobalamin was found to be 7.99 min and 1.97 min, respectively. The linearity of developed method was achieved in the range of 165-495 μg/ml for dosulepin hydrochloride and 5-15 μg/ml for methylcobalamin. The detection (LOD) and quantitation (LOQ) limits were found to be 0.75 µg/ml and 2.28 µg/ml for dosulepin hydrochloride and 0.040 µg/ml and 0.121 µg/ml for methylcobalamin respectively. In the stability studies, it was observed that there is no interference of the degradation products with drug samples.Conclusion: An accurate simple, rapid, precise, linear and stability indicating RP-HPLC method was developed for simultaneous quantitative estimation of dosulepin hydrochloride and methylcobalamin both in bulk and pharmaceutical formulation. The method was validated as per ICH guidelines. This method holds good for the routine analysis of dosulepin hydrochloride and methylcobalamin in various pharmaceutical industries as well as in academics.

scholarly journals Analisis Glimepirida Dalam Plasma Tikus

2006 ◽  
Vol 3 (1) ◽  
Author(s):  
Yahdiana Harahap ◽  
Umar Mansur ◽  
Theresia Sinandang
Keyword(s):  
High Performance ◽  
Internal Standard ◽  
Reversed Phase ◽  
Array Detector ◽  
Diode Array Detector ◽  
Chromatography Method ◽  
Mobile Phase Flow Rate ◽  
Limit Of Quantitation ◽  
Liquid Chromatography Method ◽  
The Given

The aim of this research is to find the method for analyze glimepiride and itÂ’s metabolite. Glimepiride is the second generation of antidiabetic oral from the sulphonyl urea that works by stimulating the insulin secretion from beta cells of pancreas. Glimepiride is isolated from plasma the using chloroform. Using the high performance liquid chromatography method which include C18 reversed phase column, using mixture of methanol:water (50:50, v/v) as a mobile phase, flow rate 1.0 ml/minutes, detection at wavelenght 228 nm with photo diode array detector gives retention times of glimepiride in 17 minutes without any interference from endogen component of plasma and from itÂ’s metabolite. Linearity with added internal standard gliclazide was established for the range concentration 100-1000 ng/ml with coefficient of correlation (r) is 0.9977 and give the limit of quantitation of glimepiride in 50 ng/ml. The results of validation method fulfilled for the given criterias.

scholarly journals A Quantitative, Sensitive and Rapid Validated Analytical RP-HPLC Method for the Estimation of Dapagliflozin in Bulk and Pharmaceutical Dosage Formulations

2020 ◽  
Vol 11 (2) ◽  
pp. 2543-2548
Author(s):  
Gouru Santhosh Reddy ◽  
Animesh Bera ◽  
Madhurima Basak ◽  
Krishnaveni Nagappan ◽  
Ramalingam Peraman
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Current Method ◽  
Hplc Method ◽  
Uv Detector ◽  
Limit Of Quantification ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Pharmaceutical Industries ◽  
Liquid Chromatography Method

The present study is aimed to develop a linear, precise, and accurate RP-HPLC (Reverse Phase High-Performance Liquid Chromatography) method for the determination of dapagliflozin in the formulation. The method was accomplished on a C18 column (250×4.6mm; 5µm), & Samples were eluted using acetonitrile: water (40:60%v/v) delivered at a flow rate of 1.0ml/min with a chromatographic run time of 10 min. The eluents were observed utilizing a UV detector with a wavelength set at 277nm. The method that was developed resulted in the retention of dapagliflozin at 7.029minutes. Dapagliflozin through current method has shown linearity (r2 > 0.999) over the concentration range of 1-16 µg/ml. The percentage recovery was observed to be within the limits of 98-102%, demonstrating the accuracy of the method. Limit of detection (LOD) and limit of quantification (LOQ) were qualified at 0.049µg/ml and 0.1485µg/ml, respectively. A Linear, precise, accurate, simple, and rapid RP-HPLC method has been developed and validated for the evaluation of dapagliflozin in bulk drug and tablet dosage forms (5mg &10mg) according to ICH Q2(R1) rules. Additionally, the proposed method could be of use in quality control tests of dapagliflozin in pharmaceutical industries.

scholarly journals Method Development and Validation of Salmeterol xinofoate by HPLC

2021 ◽  
Vol 6 (6) ◽  
pp. 52-63
Author(s):  
Sahebrao H. Shembade ◽  
Sagar S. Landage ◽  
Ashapak M. Tamboli ◽  
Ritesh S. Bhate ◽  
Kaustubh V. Gavali ◽  
...  
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Chromatography Method ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
Development And Validation

A rapid and precise high performance liquid chromatography method has been developed for the validation of Salmeterol xinofoate in its pure dosage form. The separation was carried out on Agilent Zorbax Bonus RP- (250mm ×4.6mm 5μ) column with a mobile phase consisting of 0.1% Formic acid: Acetonitrile in the ratio of 64:36 v/v as a mobile phase and flow rate is 1ml/min. The detection was carried out at wavelength 234nm. The column thermostatically controlled at 30℃. The retention time of Salmeterol was found to be 1.96 min. The Salmeterol xinofoate followed linearity in the concentration range of 40-60μg/mL with r2= 0.999. The developed method was validated for sensitivity, accuracy and precision. The sample was scanned from 200- 400nm with PDA detector. The % recovery of sample was found to be. The LOD and LOQ of the Salmeterol xinofoate was found to be 2.67μg/ml and 8.08μg/ml respectively. The suitability of this HPLC method for quantitative estimation of Salmeterol xinofoate was proved by validation by the requirements of ICH guidelines.

scholarly journals DEVELOPMENT OF METHODS FOR DETERMINATION OF SPECIFIC IMPURITIES IN THE GLUTATIONION RESTORED SUBSTANCE

2019 ◽  
Vol 6 (6) ◽  
pp. 535-547
Author(s):  
K. A. Alexeeva ◽  
D. I. Pisarev ◽  
A. Yu. Malyutina ◽  
N. N. Boyko
Keyword(s):  
Amino Acids ◽  
High Performance ◽  
Hplc Method ◽  
Low Molecular Weight ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Layer Chromatography ◽  
Better Than

Glutathione (γ-L-glutamyl-L-cysteinylglycine) is the most important low molecular weight intracellular thiol tripeptide consisting of three amino acids – glycine, cysteine and glutamic acid. In Russian pharmacopoeia there is no regulatory documentation for glutathione, therefore, the development of a pharmacopoeial item for the specified substance is a relevant problem.The aim of the article is the development of methods for determining foreign specific impurities in glutathione.Materials and methods. The substance of glutathione reduced (CAS 70-18-8, EC 2007254, Applichem, Germany) containing impurities, and a standard sample of reduced glutathione (Sigma Aldrich, Japan) were used as the objects of the study. The analysis was carried out by using a high-performance liquid chromatography method in the reverse phase version and a thin layer chromatography method. The chromatography using RP HPLC was performed after preliminary derivatization of glutathione and its specific impurities with dancil chloride. Specific impurities in glutathione are dipeptides and amino acids. Therefore, they, like glutathione, can react with dancil chloride. Dancil derivatives are formed, and they can be determined by chromatographic separation.Results. As a result of chromatography by the method of RP HPLC of derivatized dancil chloride glutathione it has been established that this reaction makes it possible to detect impurities in it. Glutathione derivatives are well separated by chromatography by implementing the method of RP HPLC and have different absorption maxima. The glutathione derivative had an absorption maximum at λmax=284 nm. The derivatives belonging to specific glutathione impurities absorb at λmax=288 nm and λmax=296 nm. The data obtained using RP HPLC were confirmed by TLC in the isopropanol-water (2:1) system. Three components were found out, one of which corresponds to glutathione, while two others are impurities.Conclusion. Methods for determining impurities in the glutathione substance using RP HPLC methods with preliminary derivatization with dancil chloride and TLC with ninhydrin detection have been worked out. A comparative analysis of the data obtained makes it possible to state that the OF-HPLC method with pre-column derivatization is more reliable, since it is more sensitive to impurities, and also makes it possible to study the UV profiles of impurity components better than the TLC method. Therefore, for the detection of impurities in the substance of glutathione, it is more preferable to use RP-HPLC with pre-column derivatization. The results of this study can be recommended for inclusion in the regulatory documentation on the substance of glutathione in the section “Impurities”.

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