scholarly journals Method Development and Validation of Famotidine Oral Suspension by RP-HPLC Method

2020 ◽  
Vol 11 (4) ◽  
pp. 5922-5931
Author(s):  
Prakash chand T ◽  
Elancheziyan K ◽  
Yamini R ◽  
Aysha Jadeera K A ◽  
Vijey Aanandhi M ◽  
...  
Keyword(s):  
Related Compound ◽  
Mobile Phase ◽  
Method Development ◽  
Pharmaceutical Preparations ◽  
Acetate Buffer ◽  
Reverse Phase ◽  
Organic Mixture ◽  
Compound C ◽  
Rp Hplc ◽  
Development And Validation

For perseverance of a simple, fast and selective procedure were developed in drug substance and its pharmaceutical preparations. the proposed project, a successful attempt has been made to develop a simple, accurate, economic and rapid method for the estimation and to validate the method. As a result, a simple, economical, precise and accurate method was developed and validated by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). The main objective for that is to improve the conditions and parameters, which should be followed in the development and validation. developed Reverse phase HPLC technique was done utilizing filtered and degassed pH-6.0 Acetate buffer as a Mobile phase-A and pH-6.0 Acetate buffer and organic mixture in the ratio of 30:70 as a Mobile phase-B. By using waters X-Bridge C18 (150*4.6mm), 3.5µm column separation was achieved. The flow rate and run time was 0.8mL/min and 45minutes. The detection wavelength was 265nm.The average percentage recovery for related compound-C was found to be 94.3%, 95.9%, 96.0% represents the accuracy of the method and for related compound-D was found to be 95.8, 95.4 and 96.4. The %RSD for related compound-C was found to be 5.576 and for related compound-D was found to be 1.588 represents the precision of the method. The correlation coefficient square for , related compound-C and related compound-D was found to be 0.999999, 0.9992 and 0.9991 respectively. Respective parameters met the acceptance criteria, from the results concluded that the developed method was precise and accurate.

scholarly journals Method Development and Validation of RP-HPLC Method for the Estimation of Ormeloxifene

2017 ◽  
Vol 2 (03) ◽  
pp. 78-82
Author(s):  
Anusha Shivaraj ◽  
Shireesha Battula
Keyword(s):  
Mobile Phase ◽  
Room Temperature ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Isocratic Mode ◽  
Ich Guideline

A new simple, specific, accurate, precise RP-HPLC method has been developed for the estimation of Ormeloxifene. The chromatographic separation for Ormeloxifene was achieved with mobile phase containing methanol :ACN(70:30 v/v), agilent C18 column (4.6 x150 mm) 5 μ at room temperature and UV detection at 274nm.The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Ormeloxifene was found to be 2.497min. The method was validated according to ICH guideline for linearity, specificity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LINAGLIPTIN AND EMPAGLIFLOZIN

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 68-71
Author(s):  
A Lakshmana Rao ◽  
◽  
T. Prasanthi ◽  
E. L Anusha
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of the linagliptin and empagliflozin in tablet dosage form. Chromatogram was run through Kromasil 250 x 4.6 mM, 5mM column, mobile phase containing 0.1% o-phosphoric acid buffer and acetonitrile in the ratio of 60:40%v/v was pumped through column at a flow rate of 1 mL/min. The optimized wavelength was 230 nm. Retention times of linagliptin and empagliflozin were found to be 2.759 min and 2.139 min. %RSD of the Linagliptin and Empagliflozin were found to be 0.5 and 0.6 respectively. Percentage assay was obtained as 99.91% and 100.15% for linagliptin and empagliflozin, respectively. LOD, LOQ values obtained for linagliptin and empagliflozin were 0.23 μg/ml and 0.44 μg/mL and 0.70 μg/mL and 1.34 μg/mL, respectively. Thus, the current study showed that the developed RP-HPLC method is sensitive and selective for the estimation of linagliptin and empagliflozin in combined dosage form.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF EPROSARTAN MESYLATE AND ITS IMPURITIES USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2016 ◽  
Vol 8 (4) ◽  
pp. 49 ◽  
Author(s):  
O. S. S. Chandana ◽  
D. Sathis Kumar ◽  
R. Ravichandra Babu
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase ◽  
Related Substances ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation

Objective: Our main objective is to develop an accurate and precise RP-HPLC method for the determination of Eprosartan Mesylate and its impurities. Methods: A Develosil ODS UG-5; (150 × 4.6) mm; 5 µm column was used for the Separation of drugs by a mobile phase consisting of Buffer and Acetonitrile mixture in the gradient proportion. The flow rate maintained was 0.8 ml/min and the wavelength used for detection was 235 nm.Results: The linearity was observed in the range of 0.025-50µg/ml of spiked impurities in Eprosartan Mesylate, impurity 1 and impurity 2 with a correlation coefficient of 0.99927, 0.99910 and 0.99934 respectively. The mean percentage recoveries for LOQ, 50%, 80%, 100%, 150% and 200% accuracy were found to be 101.5±1.51, 107.0±1.7, 104.6±0.4, 102.8±0.36, 101.7±0.26 and 101.3±0.15 respectively for impurities in Eprosartan Mesylate, impurity 1 and impurity 2. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation.Conclusion: The developed method is uncomplicated, accurate, sensitive and precise for the determination of related substances in the Eprosartan Mesylate. The satisfying % recoveries and low % RSD Values confirmed the suitability of the developed method for the usual analysis of Eprosartan mesylate in pharmaceuticals.

scholarly journals Review Article of Dissolution Test Method Development and Validation of Dosage Form by Using RP-HPLC

2021 ◽  
Vol 70 (1) ◽  
Author(s):  
Prachi Barsagade ◽  
Roshan Khetade ◽  
Kalyani Nirwan ◽  
Tikesh Agrawal ◽  
Santosh Gotafode ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Dosage Forms ◽  
Test Method ◽  
Dissolution Testing ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Test Method Development ◽  
Development And Validation

Dissolution is precise test method used for evaluating drug release of solid and semisolid dosage forms. It is the process by which a solid solute enters a solution. For the analysis of dissolution test method development, the Reverse Phase High Performance Liquid Chromatography is used, and it is the modern of column chromatography. In the reverse phase partition HPLC the relative polarity of the stationary and mobile phase opposite to those in normal HPLC. The main applications of the dissolution testing include biopharmaceutical characterization of the drug product, as a tool to make sure consistent product quality and to predict in vivo drug bioavailability. The article represents the current updates in dissolution testing methods by using Reverse Phase High Performance Liquid Chromatography. The validation parameters explain for the analysis of sample is accuracy, precision, repeatability, detection of limit, quantitative limit, linearity, range and robustness. Analytical method validation includes all procedure and checks required to prove the reliability of a method for quantitative determination of concentration of an analyte or series of analyte in a given sample. The conventional and novel pharmaceutical dosage forms and gives an insight to possible alternatives in drug dissolution testing design. The aim of this review is to represent all the potential standardized test methods development and validation of pharmaceutical dosage form by using RP-HPLC which are analyzed the accuracy of the dissolution sample of the dosage form.

scholarly journals Reverse-phase High-Performance Liquid Chromatography Method Development and Validation for Estimation of Glimepiride in Bulk and Tablet Dosage Form

2020 ◽  
Vol 11 (02) ◽  
pp. 296-302
Author(s):  
Aseem Kumar ◽  
Anil Kumar Sharma ◽  
Rohit Dutt
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
High Performance ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Development And Validation

The present work demonstrates a simple, rapid, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method for analyzing glimepiride in pure and tablet forms. The present method was developed using a C18 column 150 × 4.6 mm, with 5 μm, and packing L1 maintained at a temperature of 30°C. The mobile phase was prepared by dissolving 0.5 gram of monobasic sodium phosphate in 500 mL of distilled water, pH of the solution adjusted to 2.1 to 2.7 with 10% phosphoric acid, and added 500 mL of acetonitrile. The mobile phase was pumped in the highperformance liquid chromatography (HPLC) system at a flow rate of 1 mL/min, and separation was carried out at 228 nm, using an ultraviolet (UV) detector. The chromatographic separation was achieved with peak retention time (RT) at about 9.30 minutes, and the method was found to be linear over a concentration range of 40 to 140 μg/mL. The specificity of the method represented no interference of the excipients during the analysis, and stability testing after 24 hours also showed that the method is suitable and specific. The accuracy was between 99.93 to 99.96%, with limit of detection (LOD) and limit of quantitation (LOQ) being 0.354 μg/mL, 1.18 μg/mL, respectively. Satisfactory results were found for precision and robustness parameters during the development and validation stage for the analytical method. The proposed method was also adopted for the analysis of glimepiride tablets to improve the overall quality control. Using this method, symmetric peak shape was obtained with reasonable retention time. The retention time of glimepiride for six repetitions is 9.3 ± 0.1 minutes; the run time is 21 minutes. The proposed RP-HPLC method is a modification of the United States Pharmacopeia (USP) method, and it was found to be valid for glimepiride within concentration ranges 40 to 140 μg/mL, using C18 analytical columns, and isocratic elution with UV detection, and at 1 mL/min of flow rate.

scholarly journals Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and its Formulation

2018 ◽  
Vol 34 (5) ◽  
pp. 2554-2561
Author(s):  
D. China Babu ◽  
C. Madhusudhana Chetty ◽  
S. K. Mastanamma
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

A selective, sensitive RP-HPLC method was developed for the simultaneous estimation of the Ertugliflozin (ETR) and Sitagliptin (SGT) in bulk and its dosage form. The separation and determination was carried on water’s C18 column capacitate (250X4.6 mm, 5 µm particle size), retention times of Ertugliflozin and Sitagliptin were found to be 2.39 and 4.60 min respectively. The wavelength was fixed at 215nm with PDA detection. The mobile phase was consisted mixture of 0.5 mM potassium dihydrogen ortho phosphate buffer: Methanol in the ratio of 55:45 v/v, pH 5.3 was adjusted with HCl and flow of mobile phase was maintained 1mL/min. The calibration curve was linear and regression co-efficient (R2) value found to be 0.999 and concentration ranging from 37.5-112.5 and 250-750 µg/mL for Ertugliflozin & Sitagliptin respectively. The quantization limit and detection limit of the method were found 0.1 & 0.3 µg/ml and 0.4&1µg/ml for Ertugliflozin & Sitagliptin.

scholarly journals Method Development and Validation of Fludrocortisone Acetate Tablets by Reverse Phase HPLC Method

2020 ◽  
Vol 11 (4) ◽  
pp. 6826-6833
Author(s):  
Vijey Aanandhi M ◽  
Elancheziyan K ◽  
Yamini R ◽  
Prakash Chand T ◽  
Aysha Jadeera K A ◽  
...  
Keyword(s):  
Phosphate Buffer ◽  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Technique ◽  
Fludrocortisone Acetate ◽  
Development And Validation

The purpose or intent of this current study was to establish a fast and sensitive HPLC technique for the perseverance of Fludrocortisone acetate and utilizing best frequently used HPLC technique. This method had been validated as per the ICH requirements  to assure that the method consistently meets the predetermined specifications and quality attributes.Utilizing filtered and degassed pH 3.0 Phosphate buffer and Acetonitrile in the ratio 90:10 as a Mobile phase-A and pH 3.0 Phosphate buffer and Acetonitrile in the ratio 65:35 as a Mobile phase-B the established RP-HPLC technique was done. The separation was achieved by using Waters, X-Bridge Shield RP18, (150 X 4.6-mm), 3.5-µm column. Run time and Flow rate was set 45minutes and 1.2mL/min. Injection volume 100µL and wavelength was set 240nm.The correlation coefficient square for fludrocortisones acetate and Fludrocortisone Impurity was found to be 0.9991 and 0.99997. The SD and %RSD for Fludrocortisone Impurity was found to be 0.02 and 1.48 represents method precision. Following validated parameters lies within the limit. Hence, the developed method was precise, simple, fast and accurate.

scholarly journals A New Quantitative Analytical Method Development and Validation for the Analysis of Boceprevir in Bulk and Marketed Formulation

2018 ◽  
Vol 10 (03) ◽  
Author(s):  
Bhetanabotla Chandramowli ◽  
B.M Syam Kumar ◽  
D.V. R. N. Bhikshapathi ◽  
Bigala B Rajkamal
Keyword(s):  
Chromatographic Analysis ◽  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Capsule Formulation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation

A simple, precise and accurate RP-HPLC technique was developed and the developed method was validated for the regular analysis of Boceprevir. Chromatographic analysis was performed by selecting X-Terra ODS ( C18) column (4.6 mm i.d. × 250 mm, 5μ), Acetonitrile : Phosphate buffer pH -3 ( 90 : 10% v/v) as mobile phase, 1.0 ml/min as flow rate and 20μl injection volume. The LC chromatographic peak was eluted at 3.6 min at 235 nm as UV detection wavelength. The developed method was validated as per the ICH guidelines and the Validation parameters were specificity, accuracy, linearity, precision, LOD and LOQ. Linear relationship for Boceprevir established in the concentration range of 50 to 150μg/mL. Accuracy in terms of percentage recovery found in the range between 98 to 101%. LOD and LOQ values were found to be 2.3 and 7.123μg/mL respectively. The results of the method established that the new RP-HPLC method is convenient and simple in regular analysis of Boceprevir in bulk and capsule formulation.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN BY RP-HPLC

2021 ◽  
pp. 134-143
Author(s):  
Sana Tabassum ◽  
Dr.M.Sathishkumar ◽  
Dr.A.Mallik ◽  
Dr.N.Jyothi
Keyword(s):  
Key Words ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Method Development ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Run Time ◽  
Development And Validation

For the coincident evaluation of Dapagliflozin and Saxagliptin in bulk form; Chromatography was run through Intersil-ODS C18 column (250mm× 4.6mm, 5micron) Mobile phase containing Methanol: Water was pumped through the column in the ratio of 45: 55. The flow rate was 1ml/min. The temperature help was ambient i.e., upto300c. The optimized selected wavelength was 210nm. The retention time of Dapagliflozin and Saxagliptin was found to be 4.707min and6.68 min respectively. The %RSD of Dapagliflozin and Saxagliptin was found to be 0.031 and 0.036 respectively. The values of LOD and LOQ obtained from Dapagliflozin and Saxagliptin was 0.56, 1.69 and 0.57, 1.74 respectively. The retention time was decreased and the run time also decreased, so the method development was simple and economical that can be applied successfully for simultaneous estimation of combination of two anti- diabetic drugs; Dapagliflozin and Saxagliptin. KEY WORDS: Dapagliflozin and Saxagliptin, RP-HPLC.

scholarly journals Development and validation of RP-HPLC method for the estimation of omeprazole in bulk and capsule dosage forms

2012 ◽  
Vol 1 (11) ◽  
pp. 366-369 ◽  
Author(s):  
Kalakonda Sri Nataraj ◽  
Mohammad Badrud Duza ◽  
Kalyani Pragallapati ◽  
Dussa Kiran Kumar
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Accurate Method ◽  
Pharmaceutical Journal ◽  
Dosage Forms ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Development And Validation

A method for the determination of omeprazole in bulk and capsule dosage form by reverse phase high performance liquid chromatography has been developed. This is a simple, rapid, precise and an accurate method. The method was developed on a Novapak C18, (250 x 4.6 mm, 5µ) column using phosphate buffer (pH 7.4) and acetonitrile in the ratio of 60:40, v/v as a mobile phase which was pumped at a flow rate of 1.0 ml/min and detection was done at 302 nm. The retention time of the drug was found to be 7.71 min. The method was validated for accuracy, precision, linearity, specificity, robustness. The linearity was observed in the range of 20-60 ppm. The results of recovery studies indicated that the method was accurate. Hence the developed method was found to be suitable for the estimation of omeprazole in bulk and capsule dosage forms.DOI: http://dx.doi.org/10.3329/icpj.v1i11.12062 International Current Pharmaceutical Journal 2012, 1(11): 366-369

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