scholarly journals Development and Validation of a Stability-Indicating Method for the Determination of Pazopanib Hydrochloride by RP-HPLC

2021 ◽  
Vol 68 (1) ◽  
Author(s):  
Ravisankar P. ◽  
M. Nithya Satya ◽  
A. Bhavani Sailu ◽  
Sk. Rijwana ◽  
K. Harsha Sri ◽  
...  
Keyword(s):  
Quality Control ◽  
Thermal Conditions ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Tablets ◽  
Stability Indicating Method ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Routine Quality Control

A precise, accurate, highly sensitive, rapid, and reproducible stability HPLC method was developed and validated for the estimation of Pazopanib Hydrochloride (PAZO) in bulk and tablet dosage form. Decent quality chromatographic separation of Pazopanib Hydrochloride was done by using Eclipse plus C18 column (4.5 mm i.e. X 150 mm, 3.5µm particle size) (based on 99.99 % ultra-high purity silica) using mobile phase that containing 0.1 % Orthophosphoric acid: Acetonitrile (55:45 % v\v) at a flow rate of 1.0 mL/minute. The wavelength ?max of PAZO used for the detection was found to be 271.4 nm. The retention time for Pazopanib was found to 1.43 minutes. The PAZO was linear in the concentration range of 2-10 µg/mL (r2 = 0.9999) for HPLC method. The regression equation for PAZO was found to be Y = 700955 x + 28022 for HPLC. The LOD and LOQ were found to be 0.1675 ?g/mL, 0.0552 µg/mL for the HPLC method, respectively. The developed methods are validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98 – 102 %, and minimum values of % RSD indicate the accuracy of the method. The % assay of the PAZO was found to be 99.85 ± 1.2, which was in good agreement with the labeled claim. Pazopanib was subjected to stressed conditions like acidic, basic, oxidative, photolytic, and thermal conditions. The degradation results were found satisfactory. The developed gradient RP-HPLC method can be successfully practiced for the routine quality control analysis of PAZO in pharmaceutical tablets and routine quality control analysis.

scholarly journals Development, Estimation and Validation of Lisinopril in Bulk and its Pharmaceutical Formulation by HPLC Method

2012 ◽  
Vol 9 (1) ◽  
pp. 340-344 ◽  
Author(s):  
V. Bhaskara Raju ◽  
A. Lakshmana Rao
Keyword(s):  
Quality Control ◽  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Reverse Phase ◽  
Quality Control Analysis ◽  
Tablet Dosage ◽  
Routine Quality Control

An accurate and preciseHPLCmethod was developed for the determination of lisinopril. Separation of the drug was achieved on a reverse phase C8column using a mobile phase consisting of phosphate buffer and methanol in the ratio of 35:65v/v. The flow rate was 0.8 mL/min and the detection wavelength was 215 nm. The linearity was observed in the range of 20-60 μ g/mL with a correlation coefficient of 0.9992. The proposed method was validated for its linearity, accuracy, precision and robustness. This method can be employed for routine quality control analysis of lisinopril in tablet dosage forms.

scholarly journals RP-HPLC Estimation of Trospium Chloride in Tablet Dosage Forms

2012 ◽  
Vol 9 (3) ◽  
pp. 1407-1411 ◽  
Author(s):  
M. Vijaya Lakshmi ◽  
J. V. L. N. S. Rao ◽  
A. Lakshmana Rao
Keyword(s):  
Wave Length ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Reverse Phase ◽  
Trospium Chloride ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Tablet Dosage

A rapid, sensitive and precise HPLC method was developed for the estimation of trospium chloride in pure and tablet dosage forms. Seperation of the drug was achieved on a reverse phase Azilent C18column using a mobile phase consisting of phosphate buffer and acetonitrile in the ratio of 60:40v/v. The flow rate was 1 ml/min and the detection wave length 215 nm. The linearity was found in the range of 10-150 μg/ml with a correlation coefficient of 1.0000. The proposed method was validated for its sensitivity, linearity, accuracy and precision. This method was employed for routine quality control analysis of trospium chloride in tablet dosage forms.

scholarly journals Simultaneous Determination of Lamivudine, Zidovudine and Abacavir in Tablet Dosage Forms by RP HPLC Method

2010 ◽  
Vol 7 (1) ◽  
pp. 180-184 ◽  
Author(s):  
D. Anantha Kumar ◽  
G. Srinivasa Rao ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Simultaneous Determination ◽  
Internal Standard ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Potassium Dihydrogen ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Tablet Dosage

A simple, accurate and reproducible RP-HPLC method has been developed for the simultaneous determination of lamivudine, zidovudine and abacavir in tablet dosage forms. Chromatography was carried out on a HiQ Sil C 18 V column using a mobile phase consisting of 0.01 M potassium dihydrogenortho-phosphate (pH 3.0) and methanol (55:45 v/v) at a flow rate of 0.8 mL/min. The detection was made at 272 nm and stavudine was used as the internal standard for this study. The retention times for lamivudine, abacavir and zidovudine were found to be 3.8, 6.3, 8.1 min. respectively. The calibration curves were linear over the range 5-250 μg/mL for both zidovudine and abacavir and 5-140 μg/mL for lamivudine. The proposed method was validated as per ICH and USP guidelines and it was found suitable for the routine quality control analysis of the drugs in tablet dosage forms.

scholarly journals Stability Indicating RP-HPLC Method for Determination of Valsartan in Pure and Pharmaceutical Formulation

2010 ◽  
Vol 7 (1) ◽  
pp. 246-252 ◽  
Author(s):  
S. K. Patro ◽  
S. K. Kanungo ◽  
V. J. Patro ◽  
N. S. K. Choudhury
Keyword(s):  
Linear Response ◽  
Mobile Phase ◽  
Hplc Method ◽  
Forced Degradation ◽  
Control Analysis ◽  
Solution Stability ◽  
Stability Indicating ◽  
Quality Control Analysis ◽  
Rp Hplc

A simple, rapid and accurate and stability indicating RP-HPLC method was developed for the determination of valsartan in pure and tablet forms. The method showed a linear response for concentrations in the range of 50-175 µg/mL using 0.01 M NH4H2PO4(pH 3.5) buffer: methanol [50:50] as the mobile phase with detection at 210 nm and a flow rate of 1 mL/min and retention time 11.041 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, forced degradation, solution stability and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be less than 1. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis.

Simultaneous determination of Sulphadoxine and Pyrimethamine by taking Tolterodine as an internal standard in Pharmaceutical dosage form by RP-HPLC

2021 ◽  
pp. 145-150
Author(s):  
Sushil D. Patil ◽  
Pravin B. Shelke ◽  
Priti Aher ◽  
Maswood Ahmed Hafizur Rahman
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Internal Standard ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Sulphadoxine Pyrimethamine

A simple, rapid, economic, sensitive and precise HPLC method has been developed for the simultaneous determination of Sulphadoxine and Pyrimethamine in pharmaceutical dosage form by taking Tolterodine as an internal standard. The method was carried out using Phenomenex C18 (4.6ID × 250mm; 5µm) column and mobile phase comprised of methanol and Phosphate Buffer in proportion of ratio 60:40 v/v. The flow rate was 1.0mL/min and detection was carried out at 276nm. The retention time of Sulphadoxine, Pyrimethamine and Tolterodine were found to be 2.967, 4.058 and 6.908 respectively. Linearity of Sulphadoxine and Pyrimethamine in the range of 2 to 12μg/mL and 4 to 24μg/mL respectively. The % recoveries of Sulphadoxine and Pyrimethamine were found to be in between 99.93% to 99. 96 % respectively. The proposed method is suitable for the routine quality control analysis for simultaneous determination of Sulphadoxine and Pyrimethamine was in bulk and pharmaceutical dosage form.

Development and validation of RP-HPLC/UV methods for the estimation of Risedronate sodium in pure and pharmaceutical dosage form

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Ananda Thangadurai Subramaniam ◽  
Devi Velmurugan ◽  
Sambathkumar Ramanathan ◽  
Kamalakannan Dhanabalan ◽  
Jambulingam Munusamy ◽  
...  
Keyword(s):  
Dosage Form ◽  
Uv Spectroscopy ◽  
Hplc Method ◽  
Dilution Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Recent study was conducted to develop and validate analytical methods for estimation of Risedronate sodium in pure and pharmaceutical dosage form using UV Spectroscopy and               RP- HPLC method. The first method (Method A) based on the UV Spectroscopy using 0.1M Hcl as diluent lambda max was found at 261 nm. Linearity existed perceived in the concentration between 10-50 μg/ml (r 2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The second method (Method B), based on determination of Risedronate sodium tablet dosage form by RP-HPLC method.  Chromatography separation was carried out on a C18 (150X4.6 mm x5 µ) SS Column using Methanol: Ammonium formate (85:15) as the mobile phase at a flow rate of   1.0 ml/min. The chromatographic analysis was carried out in the reflectance and absorbance mode at 254 nm and retention time of the drug was found to be 1.11 ml/min for standard and tablet. Linear responses of the drug were in the concentration range of 200-1000 µg/ml. The accuracy of the method was assessed by standard dilution method and found to be 98% to              102% .The results of the analysis were validated statistically prism software. The method established was found to be simple, precise, linear, accurate and sensitive. The developed method can be used for routine quality control analysis of Risedronate sodium in pure and pharmaceutical dosage form.

scholarly journals Estimation of Nortriptyline hydrochloride in Bulk and Formulation by UV-Spectrophotometric Area Under Curve Method

2019 ◽  
Vol 9 (3) ◽  
pp. 147-150
Author(s):  
Suchita R. Abhang ◽  
Shankar M. Dhobale ◽  
Akshada D. Suryawanshi ◽  
Suresh L. Jadhav ◽  
Salim G. Patel
Keyword(s):  
Quality Control ◽  
Present Method ◽  
Area Under Curve ◽  
Dosage Form ◽  
Control Analysis ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Analysis ◽  
Curve Method ◽  
Nortriptyline Hydrochloride ◽  
Routine Quality Control

The simple, precise and accurate UV-Spectrophotometric method has been developed and validated for the estimation of nortriptyline hydrochloride in bulk and dosage form. In that work was carried out for estimation of nortriptyline hydrochloride in bulk and pharmaceutical dosage form by utilizing area under curve (AUC) method. For this purpose the wavelength range 200-400nm was selected. DMSO was used as solvent throughout the work. Linearity was observed in concentration range 5-25µg/ml (R2 =0.996) for the method. The present method was found which can be used for routine quality control analysis for spectrophotometric estimation of Nortriptyline hydrochloride in bulk and dosage form. Keywords: Nortriptyline hydrochloride, Area under curve (AUC), DMSO, UV-Spectrophotometric.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF EDOXABAN TOSYLATE IN TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (07) ◽  
pp. 47-51
Author(s):  
B. Anupama ◽  
P. Tejaswi ◽  
KNV. Chenchu Lakshmi ◽  
A. Vishwanadh
Keyword(s):  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Isocratic Mode

A rapid, simple and precise reversed phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of edoxabantosylate in tablets. The quantification was carried out using a Phenomenex C-18 column (250×4.6 mm i.d., 5µm particle size) in isocratic mode with mobile phase comprising of ammonium acetate buffer andacetonitrile in the ratio of 50:50 (V/V) at a flow rate 1 mL/min. The eluent was monitored at 240 nm. The retention time of the drug was 3.486 min. The calibration curve was linear in the concentration range of 5-25 µg/mL and per cent recovery ranged from 98.25-101.6.The developed method was validated as per ICH guidelines and the results obtained were satisfactory.The method can be applied for routine quality control analysis of edoxabantosylate in tablet dosage forms.

VALIDATION OF PROPOSED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF FENPIVERINIUM BROMIDE AND PITOFENONE HCL

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (07) ◽  
pp. 39-45
Author(s):  
S.V Nagpure ◽  
◽  
S.V Deshmane ◽  
K.R. Biyani
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Diammonium Hydrogen

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of fenpiverinium bromide and pitofenone HCl. Separation of the drug was achieved on a reverse phase Thermo Kromasil C18 Column. The method showed a linear response for concentration in the range of 1.2-2.8μg/ml for FVB 6-14 μg/ml for PFH using diammonium hydrogen orthophosphatee buffer pH 7.2: acetonitrile as the mobile phase in the ratio of 55:45, v/v with detection at 220 nm with a flow rate of 1 ml/min and retention time was 3.77min and 7.45 min for FVB and PFH respectively. The method was statistically validated for linearity, accuracy, precision and selectivity.The limit of detection and limit of quantitation was 0.0654 µg/ml and 0.1982 µg/ml for FVB and 0.0927 µg/ml and 0.281 µg/ml for PFH, respectively. In quantitative and recovery studies, % RSD was found less than 2. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis of fenpiverinium bromide and pitofenone HCl in pharmaceutical formulations.

Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form

2021 ◽  
pp. 100-104
Author(s):  
Akash Shelke ◽  
Someshwar Mankar ◽  
Mahesh Kolhe
Keyword(s):  
Cost Effective ◽  
Hplc Method ◽  
Control Analysis ◽  
Inexpensive Method ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Phase Signal ◽  
Pharmaceutical Industries ◽  
Development And Validation

Objective of the present work is to develop and validate a simple, cost effective, sensitive and fast HPLC method for the analysis of Secnidazole. A Merck-Hitachi HPLC system with Peerless Basic C18 (50mm x 4.6mm x 3μm) column is employed for the analysis using buffer: methanol (80:20, v/v) as mobile phase. Signal from Secnidazole is detected at 310nm by UV Spectrophotometer. The proposed method is fully validated and found to be linear over a workable drug concentration, accurate, precise and robust. This fast and inexpensive method is suitable for research laboratories as well as for quality control analysis in pharmaceutical industries.

Sign in / Sign up

Export Citation Format

Share Document