SIMULTANEOUS ESTIMATION OF CURCUMIN AND GEFITINIB IN BULK AND TISSUE SAMPLES (PLASMA AND BRAIN HOMOGENATE) BY RP-HPLC: APPLICATION TO A DISTRIBUTION STUDY

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (07) ◽  
pp. 59-68
Author(s):  
H Mahajan ◽  
S Savale ◽  
P Nerkar ◽  
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Internal Standard ◽  
Brain Homogenate ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Bulk Analysis ◽  
Experimental Conditions ◽  
Rp Hplc

The present study was aimed at developing a Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method for simultaneous determination of curcumin (CRM) and gefitinib (GFT) in bulk, plasma and brain homogenate. hydrochlorothiazide was used as an internal standard (IS). A new simple, rapid, selective, precise and accurate RP-HPLC method has been developed. The separation was achieved by using C-18 column (Qualisil BDS C18, 250 mm x 4.6 mm I.D.) coupled with a guard column of silica, mobile phase consisted of acetonitrile: water with 0.1% formic acid (30:70 v/v). The flow rate was 0.2 ml/min and the drug was detected using PDA detector at the wavelength of 242 nm. The experimental conditions, including the diluting solvent, mobile phase composition, column saturation and flow rate, were optimised to provide high-resolution and reproducible peaks. The method was developed and tested for linearity range of 10-60 μg/mL for bulk analysis and 200-800 ng/mL for plasma and brain homogenate. The developed method was validated as per ICH guidelines, in terms of linearity, application of the proposed method to bulk sample, recovery, precision, repeatability, ruggedness, sensitivity (LOD and LOQ) and robustness and stability study (short and long-term stabilities, freeze/thaw stability, post-preparative). The low value of % RSD showed that the method was precise within the acceptance limit of 2%. The developed method was successfully applied for the analysis of the drug in bulk as well as various marketed formulation and drug in plasma and brain distribution studies.

scholarly journals A New Approach to the RP-HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Fenofibrate in Pharmaceutical Dosage Forms

2012 ◽  
Vol 9 (3) ◽  
pp. 1223-1229 ◽  
Author(s):  
S. D. Bhinge ◽  
S. M. Malipatil ◽  
A. Jondhale ◽  
R. Hirave ◽  
A. S. Savali
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Internal Standard ◽  
Reversed Phase ◽  
Hplc Method ◽  
Raw Material ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Forms ◽  
Atorvastatin Calcium ◽  
Rp Hplc

The present manuscript describes the development and validation of an isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Atorvastatin calcium and Fenofibrate in raw material and tablet. Atorvastatin Calcium, Fenofibrate and Diclofenac (internal standard) were well separated using a reversed phase column and mobile phase consisting of acetonitrile:KH2PO4(50 mM) (72:28v/v) (pH 4.1). The mobile phase was pumped at 1.0 mL/min flow rate and atorvastatin calcium and fenofibrate were detected by UV-Vis detection at 260 nm. The retention time for atorvastatin calcium, Internal Standard and fenofibrate were 4.34, 5.35 and 12.05 min, respectively. The LOD and LOQ was found to be 1.95 and 4.80 µg/mL for atorvastatin calcium whereas for fenofibrate it was found to be 1.73 and 3.98 µg/mL in mobile phase. The developed method was validated by applying parameters as precision, accuracy, selectivity, reproducibility and system suitability tests.

scholarly journals Application of RP-HPLC method for the simultaneous determination of cetirizine in the presence of quinolones

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Hina Shamshad ◽  
Agha Zeeshan Mirza
Keyword(s):  
Human Serum ◽  
Simultaneous Determination ◽  
Flow Rate ◽  
Mobile Phase ◽  
Diclofenac Sodium ◽  
Internal Standard ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines

Abstract Background Present work describes a fast, simple, and sensitive procedure for the simultaneous determination of cetirizine in the presence of quinolones using diclofenac sodium as an internal standard. The present work was designed to analyze these compounds in pharmaceutical and clinical labs being economical for use. Results The mobile phase consisted of the simple composition of methanol, acetonitrile, and water in a ratio of 50:20:30 with a pH adjusted to 3.1 at a flow rate of 1 mL min−1. The UV detection was performed at 225 nm. The linearity was assessed over the range of 2.5–50 μg mL−1 for all drugs. The parameters such as accuracy, precision, linearity (>0.999), and sensitivity were satisfactory. Conclusion The method was equally applicable for formulation and human serum with recovery values between 95 and 105%. The results of the method were validated statistically according to ICH guidelines.

scholarly journals ANALYTICAL QUALITY-BY-DESIGN (AQBD) APPROACH FOR THE DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF LAMOTRIGINE IN BULK AND TABLET FORMULATION

2021 ◽  
Vol 10 (5) ◽  
pp. 3591-3596
Author(s):  
Manisha P. Puranik
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
High Performance ◽  
Quality By Design ◽  
Active Pharmaceutical Ingredient ◽  
Reversed Phase ◽  
Hplc Method ◽  
Analytical Technique ◽  
Rp Hplc ◽  
Ich Guideline

The current analytical exploration illustrated developing a reversed-phase high-performance liquid chromatography (RP-HPLC) technique and consequent substantiation for analyzing lamotrigine (LAM) active pharmaceutical ingredient (API) using a Quality-by-design (QbD) approach (Central Composite Design), in bulk product as well as in the tablet formulations. In this experiment, based on systematic scouting, four key components (viz., mobile phase, column, flow-rate, and wavelength) were studied by the RP-HPLC method. 13 experimental runs were done with acetonitrile (ACN) (40-60% v/v) having flow-rate in the range 0.8 mL/min to 1.2 mL/min. The proposed analytical method was thoroughly corroborated in terms of ruggedness linearity, robustness, accuracy, and precision in accordance with ICH guideline Q2A and ICH guideline Q2B. Under the optimum chromatographic environment; Intersil C8 column of 250 mm length, 4.6 mm (i.d.); 20 μL injection volume; and mobile phase ACN: Methanol (60:40 v/v), a retention time of 2.542 min was noticed at 220 nm detection wavelength. The method was found to be extremely reproducible, accurate, linear, precise, robust, and economically adequate to execute the estimation. The intended analytical technique was thoroughly assessed through statistical tools and could be an imperative concern for the habitual scrutiny of LAM in bulk products and its formulation.

RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND CANAGLIFLOZIN IN PHARMACEUTICAL FORMULATION

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (06) ◽  
pp. 49-59
Author(s):  
Hemant Kumar T ◽  
◽  
Gowri Sankar D ◽  
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Orthophosphoric Acid ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Interday Precision ◽  
Metformin Hcl

A simple, specific, accurate, precise and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of metformin HCl and canagliflozin in pharmaceutical formulation. The method was developed using the Altima C8 column (150 ×4.6 mm, 0.5 μm) with a mobile phase consisting of acetonitrile and 0.1 % orthophosphoric acid in water (62:38 %V/V) with a flow rate of 1 mL/min. Detection was carried out at 254 nm using a PDA detector. The retention time for metformin HCl and canagliflozin was found to be 2.282 and 3.339 min, respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was observed over a concentration range 15-225 μg/mL for metformin HCl (r2 =0.9995) and 5-40 μg/mL for canagliflozin (r2 =0.9988). The % RSD for intraday and interday precision was found to be 0.13 and 0.20 for metformin HCl and 0.18 and 0.20 for canagliflozin. The LOD and LOQ were found to be 0.16 μg/mL and 0.54 μg/mL for metformin HCl and LOD and LOQ were found to be 0.05 and 0.21 μg/mL for canagliflozin. Metformin HCl and canagliflozin were subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis.

scholarly journals A Validated RP – HPLC Method for Simultaneous Estimation of Cefixime and Cloxacillin in Tablets

2008 ◽  
Vol 5 (3) ◽  
pp. 648-651 ◽  
Author(s):  
G. Rathinavel ◽  
P. B. Mukherjee ◽  
J. Valarmathy ◽  
L. Samueljoshua ◽  
M. Ganesh ◽  
...  
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Phosphate Buffer ◽  
Mobile Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc

This paper presents a RP-HPLC method for the simultaneous estimation of cefixime and cloxacillin in tablets. The process was carried out on C18column (5 μm, 25 cm × 4.6 mm, i.d) using phosphate buffer (pH 5.0), acetonitrile and methanol in the ratio 80:17:3 respectively as a mobile phase at a flow rate of 2mL/min. Wavelength was fixed at 225 nm. The retention time of cefixime and cloxacillin was found to be 5.657 and 6.200 min, respectively. The developed method is rapid and sensitive and it can be used for estimation of combination of these drugs in tablets.

scholarly journals Simultaneous estimation of gabapentin and methylcobalamin in bulk and pharmaceutical dosage form by RP-HPLC

2019 ◽  
Vol 9 (1) ◽  
pp. 170-174
Author(s):  
Anjali Bakshi ◽  
K Monika ◽  
Shweta Bhutada ◽  
M. Bhagvan Raju
Keyword(s):  
Particle Size ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Gabapentin & Methylcobalamin from bulk and formulation. Chromatographic separation was achieved Isocratically on an Inertsil C18 column (150x4.6, 5µ particle size) using a mobile phase Buffer: Acetonitrile in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, effluents were detected at 264 nm and 10µl of sample was injected. Retention time of Gabapentin & Methylcobalamin was found to be 2.7 and 4.13 min respectively. Linearity of the method was in the concentration range of 25-150 µg for Gabapentin & 0.125-0.750 µg for Methylcobalamin. Percent recoveries obtained for both the drugs were 100.00%. The percentage RSD for precision of the method was found to be less than 2%. The method was validated according to the ICH guidelines. The method developed was successfully applied for the analysis of simultaneous estimation of Gabapentin & Methylcobalamin tablets and was fairly good in comparison with other methods. Keywords: Gabapentin, Methylcobalamin, HPLC.

scholarly journals RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF RITONAVIR, OMBITASVIR AND PARITAPREVIR IN TABLET DOSAGE FORMS AND THEIR STRESS DEGRADATION STUDIES

2019 ◽  
pp. 193-210
Author(s):  
SYED IBRAHIM BAJE ◽  
B. JYOTHI ◽  
N. MADHAVI
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Rp Hplc

Objective: The objective of the present study was to develop and validate a novel reverse phase high performance liquid chromatographic (RP-HPLC) method, for simultaneous determination of ritonavir (RIT), ombitasvir (OMB) and paritaprevir (PAR) in bulk mixtures, and in tablets. Methods: Determination of the drugs ritonavir (RIT), ombitasvir (OMB), and paritaprevir (PAR), was carried out applying Hypersil BDS C18 column (250 mm X 4.6 mm i.e., 5 µm particle size), with photodiode array detector at λmax of 254 nm. The mobile phase applied for the current study composed of two solvents, i.e. A (0.01N % w/v potassium di-hydrogen orthophosphate buffer, pH 3.0 adjusted with dilute orthophosphoric acid) and B (acetonitrile). The mobile phase was pumped at a flow rate of 1.0 ml/min in the isocratic mode. The validation study with respect to specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantification (LOQ) was carried out employing the ICH guidelines. Results: Ritonavir, ombitasvir, and paritaprevir showed linearity of response between 12.5-75 μg/ml for ritonavir, 3.125-18.75 µg/ml for ombitasvir and 18.75–112.5 µg/ml for paritaprevir, with a correlation coefficient (R2) 0.999, 0.999,0.999 for RIT, OMB, and PAR respectively. The % recovery obtained was 99.82±0.14 % RIT, OMB 100.03±0.96 % and for 99.96±0.26 % PAR. The LOD and LOQ values for RIT, OMB, PAR were obtained to be 0.02, 0.019and0.02, µg/ml and 0.07, 0.06 and 0.07 µg/ml, respectively. The method also exhibits good robustness for different chromatographic conditions like wavelength, flow rate, mobile phase, and injection volume. Conclusion: The method was successfully employed, for the quantification of RIT, OMB, and PAR, in the quality control of in-house developed tablets, and can be applied for the industrial use.

scholarly journals Multivariate optimization of liquid chromatographic conditions for determination of dapagliflozin and saxagliptin, application to an in vitro dissolution and stability studies

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Sunitha Gurrala ◽  
Shiva Raj ◽  
C. V. S. Subrahmanyam ◽  
Panikumar D. Anumolu
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
In Vitro Dissolution ◽  
Simultaneous Estimation ◽  
Stability Studies ◽  
Experimental Conditions ◽  
Pharmaceutical Dosage Form

Abstract Background Analytical quality by design driven HPLC method has been optimized for simultaneous estimation of dapagliflozin and saxagliptin in pharmaceutical dosage form. Response surface methodology was employed for optimization of experimental conditions using three factors such as organic phase (%), pH of aqueous phase, and flow rate of mobile phase. Results Virtuous separation of analytes was achieved with mobile phase consisted of acetonitrile: phosphate buffer, pH 5.8 (26:74% v/v) with flow rate 0.96 mL/min using SPOLAR C18 column (250 × 4.6 mm, 5 μ) with run time 6 min and UV detection at 236 nm. Retention time for dapagliflozin and saxagliptin were found to be 3.5 and 5.0 min, respectively. Method was validated as per ICH guidelines. The plot between peak area vs concentration for dapagliflozin and saxagliptin were rectilinear in the range of 0.2-300 μg/mL and 0.1-150 μg/mL respectively with detection and quantification limits were 0.061 and 0.18 μg/mL for dapagliflozin and 0.014 and 0.043 μg/mL for saxagliptin, respectively. Conclusion The proposed method was exploited for assay, in vitro dissolution, and stability studies of target drugs in marketed dosage form.

A VALIDATED RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PANTOPRAZOLE AND CINITAPRIDE IN A PHARMACEUTICAL FORMULATION

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (01) ◽  
pp. 27-33
Author(s):  
N. R Dighade ◽  
◽  
S. P. Padmane ◽  
A. V. Kasture
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Capsule Formulation ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Effluent Flow Rate

The study describes a validated stability indicating reverse- phase HPLC method for the simultaneous estimation of pantoprazole and cinitapride in capsule formulation. The proposed RP-HPLC method utilizes an Eclipse XDB C18 Column (150 × 4.6 mm i.d., 5μm), optimum mobile phase consisting of 10 mM phosphate buffer: acetonitrile: THF in the ratio of 64:36:0.5 V/V (pH 3.5) V/V, effluent flow rate 1 mL/min and UV detection wavelength of 266 nm. The selected chromatographic conditions were found to effectively separate pantoprazole and cinitapride with retention time of 7.17 min and 3.56 min, respectively. Linearity for pantoprazole and cinitapride was found in the range of 2-30 μg/mL and 0.15- 2.28 μg/mL, respectively. The developed method was statistically validated for the linearity, accuracy, precision, robustness, ruggedness and specificity. The proposed method was found to be simple, accurate, precise, economical and specific. Therefore, it can be used for simultaneous analysis of these drugs in capsule formulation.

VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION AND QUANTIFICATION OF RESERPINE AND GALLIC ACID IN AN AYURVEDIC FORMULATION

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (09) ◽  
pp. 86-88
Author(s):  
A. A Adhyapak ◽  
◽  
A. P Jadhav
Keyword(s):  
Gallic Acid ◽  
Simultaneous Determination ◽  
Flow Rate ◽  
Mobile Phase ◽  
Orthophosphoric Acid ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Water Ph

A simple, precise, accurate and robust RP-HPLC method was developed and validated for simultaneous estimation of reserpine and gallic acid in an ayurvedic formulation. The two markers were resolved using a C-18 column make Hemochrom Instil using the mobile phase acetonitrile: water (pH 5.6 adjusted using orthophosphoric acid) in the ratio 75:25 V/V at a flow rate of 0.8 mL/min. Retention times of reserpine and gallic acid were 8.178 ± 0.2 minutes and 2.527 ± 0.2 minutes respectively, at 229 nm. The developed method was validated on the basis of ICH Q2 (R1) guidelines. The developed method was applied for quantification of markers in marketed formulation, Cardostab tablet.

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