METHOD DEVELOPMENT AND VALIDATION OF VALACYCLOVIR HYDROCHLORIDE AND RITONAVIR IN TABLET DOSAGE FORM USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

2015 ◽  
Vol 76 (1) ◽  
Author(s):  
D. Sathis Kumar ◽  
B. D. N Prashanthi ◽  
A. Harani ◽  
P. Anusha
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Water Mixture ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage

Our main objective is to develop an accurate and precise RP-HPLC method for the simultaneous determination of Valacyclovir HCl and Ritonavir in tablet dosage form. An Agilent TC-C18 (2) column is used for the Separation of drugs by a mobile phase consisting of methanol, acetonitrile and water mixture in the ratio of 35:41.5:23.5v/v. The flow rate maintained was 1.3 mL/min and the wavelength used for detection was 222 nm. The linearity was observed in the range of 12.5-125µg/ml for Valacyclovir HCl (VC) and Ritonavir (RT) with a correlation coefficient of 0.9987 and 0.9981 respectively. The mean percentage recoveries for 80%, 100% and 120% accuracy were found to be 101.7%±2.09, 100%±2.49 and 101.5%±1.61 respectively for VC. The mean percentage recoveries for 80%, 100% and 120% accuracy were found to be 104.3%±0.99, 100%±1.77and 99.0%±1.22 respectively for RT. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation. The developed method can be utilized in the analysis of VC and RT tablets.

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PIOGLITAZONE IN BULK SAMPLES AS WELL AS IN TABLET DOSAGE FORMS BY USING RP -HPL C

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (09) ◽  
pp. 42-46
Author(s):  
M Debnath ◽  
◽  
A. S. Kumar ◽  
V. D. S Ganta
Keyword(s):  
Method Development ◽  
Dosage Forms ◽  
Hplc Method ◽  
Uv Detector ◽  
Pharmaceutical Dosage Forms ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise RP‐HPLC method was developed and validated for the determination of pioglitazone hydrochloride in pharmaceutical dosage forms. Chromatography was carried out using Kromosil- C18 ODS column (250 x 4.6 mm; 5 μm), mixture of acetate buffer: methanol (40:60 v/v) as the mobile phase at a flow rate 1.0 mL/min. The analyte was monitored using UV detector at 254 nm. The retention time for pioglitazone HCl was 3.063 min. The proposed method was found linear in the concentration range of 20.0‐70.0 μg/ml with correlation coefficient of r2=0.9999. The developed method has been statistically validated and found simple and accurate. The mean recoveries obtained for pioglitazone HCl were in the range 99.20-101.59%. Due to its simplicity, rapidness, high precision and accuracy of the proposed method it may be used for determining pioglitazone HCl in bulk and dosage forms.

Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

2021 ◽  
pp. 4767-4772
Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Solution Stability ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

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 NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR CEFOXITIN NEW β-LACTAM ANTIBIOTICS IN BULK AND DOSAGE FORM

2019 ◽  
Vol 8 (6) ◽  
Author(s):  
Amit Kumar
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
British Pharmacopoeia ◽  
Method Development And Validation ◽  
Novel Method ◽  
Development And Validation ◽  
Tablet Dosage

The Objective of this work based on for development of a novel method and validation of method used for determination of amount in manner of assay present into Cefoxitin in bulk and Tablet Dosage form. The aspire and intention of the present study is to expand moreover authenticate a novel as well as rapid reverse phase chromatography separation technique for the estimating Cefoxitin in bulk and dosage form to justify the presence of drug in the developed dosage forms and give satisfaction towards presence of medicine and its assay estimation. As the drug Cefoxitin compendial monograph is not available in Indian Pharmacopoeia and British Pharmacopoeia, but a compendial monograph is available in United Sate Pharmacopoeia i.e. USP- 40 for injection dosage form only. The developed method is new, simple, economic, rapid, eco friendly, accurate, and precise HPLC method for qualitative and quantitative estimation of Cefoxitin in bulk and dosage form like tablet, capsule, injection also.  

scholarly journals Method Development and Validation of Polmacoxib in Capsule Dosage Form by RP-HPLC

2021 ◽  
Vol 11 (4-S) ◽  
pp. 59-63
Author(s):  
Anjali Chaudhary ◽  
Meenakshi Dhaiya ◽  
Shaily Tyagi ◽  
Swati Mittal
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Intended Use

A simple and sensitive RP-HPLC method developed for estimation of Polmacoxib in bulk by using a high performance liquid chromatography with PDA detector using Phenomenex luna C18 column (250mmx4.6mm), 5 µm; mobile phase comprises of Water : ACN as (1:1) at the flow rate 1.0 ml/min and the wavelength of detection  238 nm and eluted at 8.12 minutes. The proposed method is validated for specificity, Linearity, Precision, accuracy, ruggedness, and Robustness. All the parameters were found within the acceptable limits. RP-HPLC method was a simple, reliable economic and acceptable and it confirmed that method is suitable for the intended use for routine quality control and assay of drugs. This method is successfully applied for the determination of commercial dosage form capsule preparation. This method is validated as per ICH (International conference on harmonization) Guidelines. Keywords: Polmacoxib, RP-HPLC, ICH, PDA Detector, Precision

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

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