scholarly journals Method Development and validating the Detection and Determination of Cinacalcet in bulk and its formulation using RP-HPLC

2020 ◽  
Vol 11 (4) ◽  
pp. 6793-6799
Author(s):  
Birendra Shrivastava ◽  
Sai Rajesh Kollapudi ◽  
Dinakar A
Keyword(s):  
Method Development ◽  
Analytical Techniques ◽  
High Sensitivity ◽  
Drug Dosage ◽  
Hplc Method ◽  
Research Literature ◽  
The Body ◽  
Calcium Sensing ◽  
Rp Hplc ◽  
Short Time

Cinacalcet (INN), a calcium mimetic drug that mimics the activity of calcium in the body. It expresses itself by activation of calcium-sensing receptor allosterically in different organs and tissues. The secretion of parathyroid hormone is regulated principally by calcium-sensing receptors that are present on the surface of the parathyroid gland. Cinacalcet is used in the treatment of hyperparathyroidism, which is the usual consequence of parathyroid cancers and CKF. There had been a rapid increase in the number of drugs that are adding to each class of drugs. These drugs are formulated into newer formulations either in a single or multi-drug dosage forms. These newer marketed formulations demand a new investigation for the estimation of the drug in the formulations. The existing analytical techniques for those drugs are available in the research literature, but not all the methods are stable and economical to use. The objective of this work was to develop an analytical RP-HPLC method for the estimation of cinacalcet in bulk and tablet formulation. The emphasis was given to the short time of analysis, and simplicity in the method. RP-HPLC analysis of the drug satisfies the peak integrity, suitability, recovery of the drug. LOQ and LOD of the drug were achieved with high sensitivity. The data shows the precision of the method and the accuracy of the method. Overall, the data suggest that the proposed analytical method can be used to analyse the drug in the formulation. This method can be recommended for the routine analysis of the drug in its dosage form.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATOMOXETINE HYDROCHLORIDE USING RAPID HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC TECHNIQUE

2018 ◽  
Vol 11 (11) ◽  
pp. 118
Author(s):  
Zubaidur Rahman ◽  
Vijey Aanandhi M ◽  
Sumithra M
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Sensitivity ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Chromatographic Technique ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: A simple, novel, sensitive, rapid high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for quantitative determination of atomoxetine HCl (ATH) in bulk and formulations.Methods: The chromatographic development was carried out on RP-HPLC. The column used as Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size), with mobile phase consisting of methanol: water 80:20 V/V. The flow rate was 1.0 mL/min and the effluents were monitored at 270 nm.Results: The retention time was found to be 5.350 min. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 2–10 μg/mL with a regression coefficient of 0.9999. The method has proved high sensitivity and specificity.Conclusion: The results of the study showed that the proposed RP-HPLC method was simple, rapid, precise and accurate which is useful for the routine determination of ATH in bulk drug and in its pharmaceutical dosage form.

RP-HPLC method development for simultaneous determination of the drugs Ramipril and Amlodipine

2012 ◽  
Vol 2 (2) ◽  
pp. 364-367 ◽  
Author(s):  
Saida Naik Dheeravath ◽  
◽  
Kasani Ramadevi ◽  
Zilla Saraswathi ◽  
Dheeravath Maniklal ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Hplc Method Development

Dronedarone HCl—Quercetin Co-Amorphous System: Characterization and RP—HPLC Method Development for Simultaneous Estimation

2021 ◽  
Author(s):  
Navya Sree K S ◽  
Swapnil J Dengale ◽  
Srinivas Mutalik ◽  
Krishnamurthy Bhat
Keyword(s):  
Method Development ◽  
Hplc Method ◽  
Molar Ratio ◽  
Simultaneous Estimation ◽  
Content Uniformity ◽  
Amorphous System ◽  
Simultaneous Quantification ◽  
Linearity Range ◽  
Rp Hplc ◽  
Economic Method

Abstract Background Dronedarone HCl is an anti-arrhythmic drug indicated for atrial fibrillation. Dronedarone HCl(DRN) has a low solubility of 2 µg/mL and 4% bioavailability, thus it is formulated as co-amorphous system to enhance its solubility by using Quercetin(QCT) as coformer. Literature lacks a sensitive, accurate and economic method for simultaneous quantification of DRN and QCT in formulation. Objective To develop a RP-HPLC method for simultaneous estimation of DRN and QCT in DRN-QCT co-amorphous system. Method Co-amorphous system was prepared using solvent evaporation technique using DRN and QCT in 1:1 molar ratio. The separation was achieved on Purospher® STAR C18 (250 mm × 4.6 mm × 5 μm) column with mobile phase comprising of Acetonitrile and 25 mM phosphate buffer pH 3.6 (60:40, % v/v). Results DRN and QCT retained at 6.7 and 3.5 min, respectively. For both molecules, method was developed with a wide linearity range of 0.2–500 µg/mL. LOD for DRN was found to be 0.0013 and 0.0026 µg/mL for QCT. Also, LOQ for DRN was found to be 0.0041 and 0.0078 µg/mL for QCT. Conclusion Method was validated as per ICHQ2R1 guidelines for linearity, precision, accuracy, and robustness. The method was used in simultaneous quantification of DRN and QCT in co-amorphous samples. Highlights The method developed was used for the analysis of content uniformity and solubility samples of co-amorphous system, where the method was able to successfully quantify DRN and QCT. Low detection and quantification limits contribute to sensitivity of the method and wide linearity range assures the robust and precise quantification of molecules.

RP-HPLC Method Development and Validation for the Estimation of Sacubitril and Valsartan in Pharmaceutical Dosage Form

2021 ◽  
pp. 5797-5802
Author(s):  
G.M. Kadam ◽  
A.L. Puyad ◽  
T.M. Kalyankar
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Content Uniformity ◽  
Phase Detection ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Hplc Method Development

A new, economical, simple, accurate, and precise RP-HPLC method was developed for simultaneous assay and content uniformity determination of Sacubitril and Valsartan in bulk and pharmaceutical dosage form. The separation of Sacubitril and Valsartan was achieved within 6 minutes on Phenomenex Luna C18 250 mm x 4.6mm and 5µm Particle Size, column using Acetonitrile: Methanol: Water (30:55:15% v/v/v) as the mobile phase. Detection was carried out at 250 nm wavelength. The retention time of Sacubitril and Valsartan was found to be 2.361 and 3.304 min, respectively. The validation of the developed method was performed in terms of specificity, accuracy, precision, linearity, the limit of detection, the limit of quantification as mentioned in International Conference on Harmonization (ICH) guidelines. The method showed adequate sensitivity concerning linearity, accuracy, and precision over the range 12-36 μg/ml and 13-39 μg/ml for Sacubitril and Valsartan, respectively. The percentage recoveries obtained for Sacubitril and Valsartan were found to be in the range of 98.00 – 102.00 %. The proposed method is suitable for use in quality-control laboratories for quantitative analysis.

Stability Indicating Assay Method Development and Validation of Simultaneous Estimation of Chlorzoxazone, Diclofenac Sodium and Paracetamol in Bulk Drug and Tablet by RP-HPLC

2021 ◽  
pp. 5024-5028
Author(s):  
Krutika Patel ◽  
Sudheer Kumar Verriboina ◽  
S.G. Vasantharaju
Keyword(s):  
Method Development ◽  
Diclofenac Sodium ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug

A simple, accurate, specific and stability-indicating RP-HPLC method was developed for simultaneous determination of chlorzoxazone, diclofenac sodium and paracetamol, using C18 Vydac Monomeric 120A (250 × 4.6mm, 5μ) at 40ºC. The mobile phase contains a mixture of 20mM potassium dihydrogen phosphate buffer (pH 6.2 adjusted with potassium hydroxide) and acetonitrile (30:70 v/v). The flow rate was 1ml/min and detection was carried out at 275nm using PDA detector. The retention time of paracetamol, chlorzoxazone and diclofenac sodium were 3.28mins, 13.27mins and 15.61mins respectively. The analytical curve was linear over a concentration range of 0.65- 6.5μg/ml for paracetamol, 1-10μg/ml for chlorzoxazone and 0.1-1μg/ml for diclofenac sodium. The drugs in bulk and tablet were subjected to acid and alkali hydrolysis, oxidation, thermal and photolytic degradation. This method can be successfully employed for simultaneous quantitative analysis of Chlorzoxazone, Diclofenac sodium and Paracetamol in bulk drug and tablet formulation.

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