scholarly journals Development and Validation of a RP-HPLC Method for the Simultaneous estimation of Amoxicillin, Omeprazole and Tinidazole in fixed dose combinations

2021 ◽  
Vol 11 (5-S) ◽  
pp. 57-62
Author(s):  
Basant Lal ◽  
Manish Jaimini ◽  
Devesh Kapoor
Keyword(s):  
Method Validation ◽  
Method Development ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Internal Diameter ◽  
Chromatographic Technique ◽  
Uv Detector ◽  
Rp Hplc ◽  
Dose Combination

New liquid chromatographic technique was established for the simultaneous estimation of tinidazole, omeprazole and amoxicillin in the fixed dose combination (HP-KIT by Sun Pharma). RP-HPLC elution has performed by using the Phenomenex Luna column (250 mm x 4.6 mm) having internal diameter and the packing material of size 5µm) in isocratic mobile phase of solution A: acetonitrile at a ratio of 80:20 v/v (Solution A consists of Buffer: Acetonitrile: Methanol: Triethylamine in the ratios of 68:22:10:0.01 respectively). The selected flow rate was kept as 1 ml/min and selected wavelength was 230 nm was for detection of the drugs in UV detector. As per the ICH guidelines, the method validation was carried out. Moreover, the different parameters of method such as precision, specificity, linearity, robustness and accuracy were established. The time of retention for the tinidazole, amoxicillin, and omeprazole were 4.021 2.324, and 7.332 minutes respectively. The RP-HPLC approach was robust and accurate, so it is appropriate for repetitive assay of drugs and quality control. This method is effectively used for the assessment of marketable dosage form preparation. Keywords: RP-HPLC, Amoxicillin, Tinidazole, Omeprazole, Method Development, Method Validation.

scholarly journals Simultaneous estimation of Curcumin and Gefitinib in bulk by using RP-HPLC technique with PDA detector

2018 ◽  
Vol 10 (1) ◽  
pp. 1-8
Author(s):  
Sagar Kishor Savale
Keyword(s):  
Chromatographic Method ◽  
Method Development ◽  
Estimation Method ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Dose Combination ◽  
Hplc Method Development ◽  
Development And Validation

Plan: RP-HPLC method development and validation for the simultaneous estimation of curcumin and Gefitinib in bulk. Preface: RP-HPLC chromatographic method the been widely employed in the determination of individual components in a mixture or fixed dose combination. For the ternary mixture containing Curcumin and Gefitinib, no chromatographic method for simultaneous evaluation has been reported so far. Thus our aim is to develop a simultaneous estimation method for curcumin and gefitinib by using an RP-HPLC method using a PDA detector. Methodology: The method was validated as per ICH guidelines. The recovery studies confirmed the accuracy and precision of the method. Outcome: The proposed method was found to be accurate, repeatability and consistent. It was successfully applied for the analysis of the drug in the marketed formulation and could be effectively used for the routine analysis of formulation containing the drug without any alteration in the chromatography conditions.

scholarly journals RP-HPLC Method Development and Validation for Simultaneous Estimation of Clarithromycin and Paracetamol

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Sadana Gangishetty ◽  
Surajpal Verma
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Development And Validation

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of clarithromycin (CLA) and paracetamol (PCM). C18 column (Kromasil ODS, 5 µm, 250 × 4.6 mm) and a mobile phase containing phosphate buffer (0.05 M) along with 1-octane sulphonic acid sodium salt monohydrate (0.005 M) adjusted to pH 3.2: acetonitrile (50 : 50 v/v) mixture was used for the separation and quantification. The flow rate was 1.0 mL/min and the eluents were detected by UV detector at 205 nm. The retention times were found to be 2.21 and 3.73 mins, respectively. The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75–175 µg/mL for both drugs. The developed method was applied successfully for assay of clarithromycin and paracetamol in their combined in-house developed dosage forms and in vitro dissolution studies.

scholarly journals Analytical method development and validation for simultaneous estimation of Fimasartan Potassium Trihydrate and Cilnidipine in synthetic mixture by HPLC for the treatment of hypertension stage-II

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Radhika G. Sojitra ◽  
Urvi J. Chotaliya
Keyword(s):  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Cost Effective ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Method Development And Validation ◽  
Dose Combination ◽  
Development And Validation

Abstract Background A specific, accurate, precise, robust, and cost-effective HPLC method was developed and validated for quantitative analysis of Fimasartan Potassium Trihydrate and Cilnidipine in fixed-dose combination. The isocratic elution was accomplished by Symmetry C18 column (150 mm × 4.6 mm, 5 µm) at 25 °C. Mobile phase composition is Methanol: Acetonitrile: Potassium Dihydrogen Phosphate buffer (pH 3) (60:05:35%v/v/v) at a flow rate of 1.0 mL/min, injection volume 20 µL with DAD detection at 240 nm. Result Fimasartan Potassium Trihydrate and Cilnidipine were eluted with retention time 2.65 min and 5.51 min respectively. This method was validated as per ICH guideline (Q2 R1). The calibration plots were over the concentration range of 15–90 μg/mL and 2.5–15 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine with correlation coefficient 0.9992 and 0.9989 respectively. Accuracy was obtained between 99.51–101.65% and 100.06–101.20% for Fimasartan Potassium Trihydrate and Cilnidipine respectively. LOD were found to be 0.97 μg/mL and 0.57 μg/mL and LOQ were found to be 2.95 μg/mL and 1.75 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine respectively. Conclusion The results showed that the developed method is reliable for the routine analysis for simultaneous determination of Fimasartan Potassium Trihydrate and Cilnidipine.

scholarly journals RP-HPLC Method development, Validation and Forced Degradation for Simultaneous estimation of Benserazide HCl and Levodopa in a Marketed Formulation

2020 ◽  
Vol 13 (3) ◽  
pp. 206-216
Author(s):  
Madhusudan Bhoir ◽  
Nutan Rao
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Uv Detector ◽  
Column Temperature ◽  
Rp Hplc ◽  
Liquid Chromatographic

The objective of the study was to develop and validate a novel, stability indicating, simple, rapid, accurate, precise and isocratic reverse-phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of benserazide HCl and levodopa in a marketed formulation. Chromatographic separation was achieved by using C18 Cosmosil 4.6 × 250 mm column with a mixture of phosphate buffer pH 2 and acetonitrile in proportion of 95:5 as mobile phase at a flow rate of 1.0 ml/min and column temperature 25°C. The detection was carried out at 210 nm using UV detector. The retention time for benserazide and levodopa was found to be 3.1 minutes and 6.6 minutes respectively and recoveries from tablet were between 98 and 102 %.

scholarly journals RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ASPIRIN AND OMEPRAZOLE IN BULK AND DOSAGE FORM

2018 ◽  
Vol 8 (5) ◽  
pp. 322-328
Author(s):  
Tukaram K Sarode ◽  
Prerana B Jadhav
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Water Ph ◽  
Hplc Method Development ◽  
Development And Validation

RP-HPLC method was developed for the determination of Omeprazole (OME) & Aspirin (ASP) in bulk and dosage form. Mobile phase use for the separation of OME & ASP is methanol and 0.05%OPA in water (pH= 3.5) with ratio of 60:40. The Colum used as C18 (Cosmosil) 4.6×150mm and flow rate 0.7mL/min. UV detector is used and the detection wavelength is 231nm. Retention time of OME and ASP are 4.61 & 8.03 min, respectively. This method was validated as per ICH guidelines. Linearity was observed at 10-50µg/mL of OME and 20-100µg/mL of ASP. The % RSD is found to be less than 2%.The resolution between OME and ASP is 11.55 and the tailing factors of both are less than 2.0.Therotical plates for OME and ASP are 5060, and 9367, respectively. Total run time is 15min. The developed RP-HPLC method was accurate, precise, selective and rapid for simultaneous estimation of Omeprazole and Aspirin in the pharmaceutical dosage form.” Keyword: Omeprazole, Aspirin, RP-HPLC validation.

A Novel Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Bictegravir, Emtricitabine and Tenofovir in Pure and Fixed Dose Combination

2019 ◽  
Vol 4 (1) ◽  
pp. 7-13
Author(s):  
G. Vijay Swaroop Singh ◽  
T.E. Divakar
Keyword(s):  
Method Development ◽  
Sodium Perchlorate ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stress Degradation ◽  
Dose Combination ◽  
Bulk Drug

A novel, simple, precise, accurate stability indicating liquid chromato-graphy method was developed for the separation and simultaneous quantification of bictegravir, emtricitabine, tenofovir in bulk drug and pharmaceutical formulations. Separation was achieved on ProntoSILHypersorb ODS C18 column using mobile phase of 0.1 M sodium perchlorate, methanol in the ratio of 65:35 (v/v), pH 4.8 at a flow rate of 1.0 mL/min and UV detection was monitored at a wavelength of 258 nm. In these conditions, well resolved peaks were observed with acceptable system suitability at a retention time of 4.6 min for bictegravir, 7.0 min for emtricitabine and 10.1 min for tenofovir. Very high correlated linearity range was found to be 5-30 μg/mL for bictegravir, 20-120 μg/mL for emtricitabine and 2.5-15 μg/mL for tenofovir. The method can separate and identify the unknown degradation compounds formed during stress degradation study.

Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination

2018 ◽  
Vol 42 (4) ◽  
pp. 2459-2466 ◽  
Author(s):  
N. Singh ◽  
P. Bansal ◽  
M. Maithani ◽  
Y. Chauhan
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Dose Combination ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise stability indicating method for the simultaneous estimation of dapagliflozin and saxagliptin in combined tablet dosage form was developed and validated using RP-HPLC.

scholarly journals Development and validation of a new analytical RP-HPLC method for simultaneous determination of Glibenclamide and Atenolol in bulk

2019 ◽  
Vol 10 (3) ◽  
pp. 2433-2445
Author(s):  
Anitha P ◽  
Ramkanth S ◽  
Satyanarayana S V
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Development And Validation ◽  
First Time

A new, simple, reliable, fast, sensitive and economical RP-HPLC method was developed and validated for simultaneous estimation of two fixed-dose combinations frequently prescribed in coexisted chronic diseases such as diabetes (GLB) and hypertension (ATN) in bulk for the first time. The mobile phase used for the chromatographic runs consisted of 0.01N potassium dihydrogen ortho phosphate (pH 4.8) and acetonitrile (55:45, v/v). The separation was achieved on column (BDS C18 250 x 2.1mm, 1.6m) using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 235.0 nm. The method was linear at the concentration range 2.5-15µg/ml for Glibenclamide (GLB) and 6.25-37.5µg/ml for Atenolol (ATN), respectively. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The method was validated for system suitability, linearity, accuracy, precision, detection, quantification limits and robustness and was found it is acceptable in the range of 2.5–15 µg/ml for GLB and 6.25–37.5 µg/ml for ATN. The LOD and LOQ of GLB was found to be 0.48 µg/ml and 1.47µg/ml and for ATN was found to be 0.72µg/ml and 2.20 µg/ml, respectively. The method was applied to drug interaction studies of GLB with ATN to illustrate the scope and application of the methods to manage two different therapeutic classes of drugs, as they may co-administered in concurrent diseases.

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