Simple, Accurate and Efficient High Performance Liquid Chromatographic Method for Determination of Vandetanib in Bulk and in Pharmaceutical Forms

Hplc Method ◽

Ich Guidelines ◽

Tablet Dosage ◽

A simple, selective, linear, precise and accurate isocratic RP-HPLC method was developed and validated for rapid assay of Vandetanib, an anticancer drug, in both bulk and tablet dosage form. Elution at a flow rate of 1ml/min was employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of acetonitrile, water and orthophosphoric acid in the ratio of 90:08:02 (v/v/v). Linearity was observed in concentration range of 50-200 ppm. The retention time for Vandetanib was 3.326 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Vandetanib in pharmaceutical dosage forms. Moreover the detection alone was also verified through LC-MS of the Vandetanib drug using ESI method which provides future scope for study of this drug using LC-MS method also.

REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF REGORAFENIB IN TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.55.06.11047 ◽

2018 ◽

Vol 55 (06) ◽

pp. 63-68

Author(s):

R. Raut ◽

◽

A. Patil ◽

V. K Munipalli ◽

M. Patel ◽

...

Keyword(s):

High Performance ◽

Dosage Form ◽

Hplc Method ◽

Control Analysis ◽

Reverse Phase ◽

Ich Guidelines ◽

Tablet Dosage ◽

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mm× 4.6mm id, 3μ) column with mobile phase consisting of Trifluoroacetic acid (0.2% v/v) and Acetonitrile in the ratio of (50: 50 v/v) at 400C in an isocratic mode was used. The detection was carried out at 260 nm and 20μL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 μg/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.

Theophylline Determination in Pharmaceuticals Using a Novel High-performance Liquid Chromatographic Process

NeuroQuantology ◽

10.14704/nq.2021.19.7.nq21103 ◽

2021 ◽

Vol 19 (7) ◽

pp. 196-208

Author(s):

H.N.K. AL-Salman ◽

Ekhlas Qanber Jasim ◽

Hussein H. Hussein

Keyword(s):

High Performance ◽

Orthophosphoric Acid ◽

Hplc Method ◽

International Conference ◽

Rp Hplc ◽

Ich Guidelines ◽

Chromatographic Process ◽

Objective: The current study aims to find a suitable, accurate, and faster RP-HPLC technique for the determination of theophylline, which could then be validated in accordance with the International Conference on Harmonization (ICH) guidelines. The Aim of this Study: The aim of this study was to develop an efficient, accurate, and faster RP-HPLC method for determining theophylline, which was then validated using the International Conference on Harmonization (ICH) guidelines. Methods: In the HPLC analysis, the Waters 2695 was used. The drug was isolated better using an Ion Pac zorbax 300-SCX Agilent Column, 5 m, 4.6 250 mm, with a liquid phase of Orthophosphoric acid (0.1 percent Orthophosphoric acid in HPLC acetonitrile and Methanol in the ratio of 50:50 v/v at a flow rate of 1ml/min, with discovery at 280 nm using a PDA detector. Results: Theophylline's preservation time was discovered to be 3.747 0.127 min. In the 5-25 mg/l range, the procedure was found to be linear, with a parallel coefficient (R2) of 0.9998. The LOD and LOQ of the system were determined to be (0.99 and 3) g/ml, respectively. The technique and system precisions were predicted using, and the outcomes were determined as percent RSD principles, which were noticed to be within the strict limitations. Theophylline recovery was detected to be in the 99-100 percent range, confirming the method's precision. Conclusion: Using basic ICH guidelines, the suggested RP-HPLC process was validated. The following methodology can be used successfully and easily for routine diagnostic analysis.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OFTRANDOLAPRIL AND VERAPAMIL IN COMBINED TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.49.05.p0061 ◽

2012 ◽

Vol 49 (05) ◽

pp. 61-64

Author(s):

A. L Rao ◽

◽

R. V Bhaskara

Keyword(s):

High Performance ◽

Dosage Form ◽

Hplc Method ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Tablet Dosage ◽

A reverse phase high performance liquid chromatographic method was developed and validated asper ICH guidelines for estimation of trandolapril and verapamil in combined tablet dosage form. Theseparation was obtained using a mobile phase consisting of acetonitrile and phosphate buffer adjustingpH to 3.0 in the ratio of 70:30 v/v and using Waters C18 (250 x 4.6 mm, 5 mcm) column maintained atambient temperature. The flow rate was 1.2 mL min-1 and UV detection was monitored at 215 nm. Theretention time (min) and linearity range (mcg mL-1) for trandolapril and verapamil were (5.12, 2.70) and(20-60, 20-60), respectively. The method validation results are within the acceptance criteria for precision,accuracy and linearity. The proposed method was found to be suitable for routine quality control ofmarketed formulation containing these APIs.

Estimation of Lamotrigine by RP-HPLC Method

E-Journal of Chemistry ◽

10.1155/2010/754745 ◽

2010 ◽

Vol 7 (s1) ◽

pp. S203-S208

Author(s):

D. Anantha Kumar ◽

CH. Venkata Kumar ◽

P. Seetharamaiah ◽

J. V. L. N. Seshagiri Rao

Keyword(s):

High Performance ◽

Potassium Dihydrogen Phosphate ◽

Dosage Forms ◽

Hplc Method ◽

Dihydrogen Phosphate ◽

Tablet Dosage ◽

A rapid and reproducible reverse phase high performance liquid chromatographic method has been developed for the estimation of lamotrigine in its pure form as well as in pharmaceutical dosage forms. Chromatography was carried out on a Luna C18column using a mixture of potassium dihydrogen phosphate buffer (pH 7.3) and methanol in a ratio of 60:40 v/v as the mobile phase at a flow rate of 1.0 mL/min. The detection was done at 305 nm. The retention time of the drug was 6.1 min. The method produced linear responses in the concentration range of 10 to 70 μg/mL of lamotrigine. The method was found to be reproducible for analysis of the drug in tablet dosage forms.

A VALIDATED ANALYTICAL HPLC METHOD FOR THE QUANTIFICATION OF LINCOMYCIN HYDROCHLORIDE IN BULK AND SOLID DOSAGE FORM

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2017v9i3.17327 ◽

2017 ◽

Vol 9 (3) ◽

pp. 42

Author(s):

P. Rajeev Kumar ◽

Rekha Rajeevkumar

Keyword(s):

High Performance ◽

Hplc Method ◽

Solid Dosage ◽

Rp Hplc ◽

Specificity And Sensitivity ◽

Ich Guidelines ◽

Objective: Develop a simple isocratic reverse phase high performance liquid chromatographic method (RP-HPLC) and validate for the determination of lincomycin hydrochloride (LMH) in bulk and pharmaceutical preparations.Methods: RP-HPLC quantification was carried out by using fine pack SIL RPC18 column. The mobile phase (methanol: water) was pumped at a flow rate of 1 ml/min in the ratio of 90:10 v/v and the eluents were monitored at 254 nm.Results: The retention time of the drug was 3.73 min and produced at a linear response in the concentration range of 5-25µg/ml. The percentage RSD was found to be below 2%. The LOD and LOQ were found to be 0.854µg/ml and 0.258µg/ml respectively.Conclusion: Validation of the method was performed for precision, accuracy, linearity, ruggedness, specificity and sensitivity to conform to ICH guidelines for valuation for analytical methods.

Validated RP-HPLC Method for Analysis of Aripiprazole in a Formulation

E-Journal of Chemistry ◽

10.1155/2010/935279 ◽

2010 ◽

Vol 7 (3) ◽

pp. 827-832 ◽

Cited By ~ 3

Author(s):

R. Kalaichelvi ◽

B. Thangabalan ◽

D. Srinivasa Rao

Keyword(s):

High Performance ◽

Reversed Phase ◽

Hplc Method ◽

Rp Hplc ◽

Relative Standard ◽

Tablet Dosage ◽

A rapid, simple and validated reversed-phase high-performance liquid chromatographic method has been developed for analysis of aripiprazole in tablet dosage form. Aripiprazole was separated on an ODS analytical column with a 40:60 (v/v) mixture of acetonitrile and triethanolamine buffer (5 mM, pH 3.5 ± 0.05 adjusted by addition of 85% phosphoric acid) as mobile phase at a flow rate of 1.5 mL min-1. The effluent was monitored by UV detection at 254 nm. Calibration plots were linear in the range of 20 to 60 µg mL-1and the LOD and LOQ were 0.411 and 1.248 µg mL-1, respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of aripiprazole in tablets.

RP-HPLC METHOD FOR ESTIMATION OF LORNOXICAM IN TABLETS AND IN DISSOLUTION SAMPLES USING MASS SPECTROMETRIC COMPATIBLE BUFFERS

INDIAN DRUGS ◽

10.53879/id.58.07.12068 ◽

2021 ◽

Vol 58 (07) ◽

pp. 32-37

Author(s):

Vijaya Lakshmi Marella ◽

Chaitanya S. N ◽

Keyword(s):

High Performance ◽

Limit Of Detection ◽

Hplc Method ◽

Mass Spectrometric ◽

Control Analysis ◽

Limit Of Quantification ◽

Ich Guidelines ◽

A selective and sensitive reverse phase High Performance Liquid Chromatographic method has been developed and validated for the estimation of lornoxicam in bulk, pharmaceutical dosage forms and in dissolution samples. The analysis was performed isocratically on an Inertsil column (250* 4.6 mm, 5 µm) using a mass spectrometric compatible mobile phase of 10 mM ammonium acetate: acetonitrile (50:50 V/V) at a flow rate of 1 mL/min.The detection wavelength was 290 nm. The retention time was found to be 4.573 min for lornoxicam. The linearity of the method has been satisfied with Beer Lambert’s law in the concentration range of 5-25 µg/mL with a correlation coefficient of 0.9988. The mean recoveries assessed for lornoxicam were in the range of 100.39-101.86 %, indicating good accuracy of the method. The limit of detection and limit of quantification were found to be 0.03 and 0.11 µg/mL, respectively. The developed method has been statistically validated in accordance with ICH guidelines and found to be mass spectrometric compatible, simple, precise, and accurate with the prescribed values. Thus, the proposed method was successfully applied for the estimation of lornoxicam in routine quality control analysis of bulk, formulations and in dissolution samples.

DEVELOPMENT OF VALIDATED RP-HPLC METHOD FOR THE QUANTITATIVE ANALYSIS OF CHROMIUM PICOLINATE III IN A DIET VINEGAR FORMULATION

INDIAN DRUGS ◽

10.53879/id.50.05.p0048 ◽

2013 ◽

Vol 50 (05) ◽

pp. 48-52

Author(s):

A Lodhi ◽

◽

A Jain ◽

B. Biswal

Keyword(s):

High Performance ◽

Limit Of Detection ◽

Reversed Phase ◽

Hplc Method ◽

Chromium Picolinate ◽

Limit Of Quantification ◽

A validated high performance liquid chromatographic method was developed for the determination of chromium picolinate in pharmaceutical dosage forms. The analysis was performed at room temperature using a reversed-phase ODS, 5µm (250×4.6) mm column. The mobile phase consisted of acetonitrile: buffer (60:40 V/V) at a flow rate of 0.5 mL/min. The PDA-detector was set at 264 nm. The developed method showed a good linear relationship in the concentration range from 1.5 – 12.5 µg/mL with a correlation coefficient from 0.999. The limit of detection and limit of quantification were 0.0540513 and 0.1637919 µg/mL respectively.

DEVELOPMENT AND VALIDATION OF A NEW RP HPLC METHOD FOR ROUTINE DETERMINATION OF TEA TREE OIL IN BULK AND COSMECEUTICAL FORMULATIONS

INDIAN DRUGS ◽

10.53879/id.56.07.11802 ◽

2019 ◽

Vol 56 (07) ◽

pp. 43-49

Author(s):

B.P. Manjula ◽

V. G Joshi ◽

Siddamsetty Ramachandra Setty ◽

M Geetha ◽

Keyword(s):

High Performance ◽

Reversed Phase ◽

Hplc Method ◽

Tea Tree Oil ◽

Tea Tree ◽

Development And Validation ◽

Tea tree oil, an active ingredient of skin, hair and nail care cosmeceuticals, has claims for topical antimicrobial, analgesic and anti-inflammatory activity. Its complex composition is governed by ISO 4730:2017. Terpinene-4-ol is the principal constituent of the oil (35% - 48%) followed by γ-terpinene (14% -28%), α-terpinene (6%-12%) and 1,8-cineole (≤15%). A reversed-phase, isocratic high performance liquid chromatographic method has been developed and validated for routine determination of tea tree oil based on1,8-cineole content in bulk and commercially available cosmeceuticals using C18 column, methanol-water (70:30 v/v) as mobile phase and flow rate of 1mL/min. UV detection was done at 200 nm. Linearity of the method was established for 20-100μL/mL (R2 = 0.9992) with LOD, LOQ values of 0.5594 μL/mL and 5.5941μL/mL respectively. The % RSD values for robustness and precision were <1% and recovery ranged between 99.09-102.96%. The method was successfully applied for determination of 1,8-cineole content in cosmeceuticals.

SIMULTANEOUS DETERMINATION OF FROVATRIPTAN, ALMOTRIPTAN AND ZOLMITRIPTAN IN COMBINED PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

INDIAN DRUGS ◽

10.53879/id.49.09.p0027 ◽

2012 ◽

Vol 49 (09) ◽

pp. 27-32

Author(s):

V. S Reddy ◽

◽

T. E. G. K. Murthy ◽

N Usha Rani ◽

R. S Rao ◽

...

Keyword(s):

High Performance ◽

Limit Of Detection ◽

Hplc Method ◽

Simultaneous Estimation ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

A simple, precise, accurate, reproducible, robust reverse phase high-performance liquid chromatographic method was developed for the simultaneous estimation of frovatriptan, almotriptan and zolmitriptan in bulk and pharmaceutical dosage forms. The method was validated as per ICH and FDA guidelines. Analysis of the drugs was performed on Phenomenex Chromosil C-18 (250 x 4.6 mm, 5 mc) column, in an isocratic mode employing methanol, acetonitrile and THF in the ratio of 46:50:04 (v/v/v) as mobile phase. UV-visible detector at 269 nm was found to be suitable for detection. Linearity was observed in the range of 40-100 ppm.The % recovery was found to be 99.51, 99.69 and 99.34 for frovatriptan, almotriptan and zolmitriptan respectively. The % RSD values for method precision was found to be 0.86, 0.65 and 1.28 for frovatriptan, almotriptan and zolmitriptan respectively. Limit of quantification (LOQ) and limit of detection (LOD) values were found to be 0.15, 0.08 and 0.09 ppm. and 0.05, 0.02, 0.03 for frovatriptan, almotriptan and zolmitriptan respectively.