RP-HPLC method validation for fast extraction and quantification of Levonorgestrel drug from silicone based intrauterine device intended for in-process and finished formulation

2021 ◽  
Author(s):  
Midhu George Veeran ◽  
Karthikeyan C. ◽  
Bharaniraja B. ◽  
Diksha Painuly ◽  
Abi Santhosh Aprem
Keyword(s):  
Method Validation ◽  
Intrauterine Device ◽  
Hplc Method ◽  
Rp Hplc ◽  
Fast Extraction

Validated RP-HPLC Method for Simultaneous Determination of Ribavirin, Sofosbuvir and Daclatasvir in Human Plasma: A Treatment Protocol Administered to HCV Patients in Egypt

2019 ◽  
Vol 57 (7) ◽  
pp. 636-643 ◽  
Author(s):  
Aya A Youssef ◽  
N Magdy ◽  
Lobna A Hussein ◽  
A M El-Kosasy
Keyword(s):  
Human Plasma ◽  
Method Validation ◽  
Treatment Protocol ◽  
Internal Standard ◽  
Gradient Elution ◽  
Hplc Method ◽  
Array Detector ◽  
Therapeutic Drug ◽  
Bioanalytical Method Validation ◽  
Rp Hplc

Abstract Egypt has the highest prevalence of hepatitis C virus (HCV) in the world thus it launched a national program for eliminating HCV aiming to treat 300,000 HCV patients per year. Three anti-HCV co-administered drugs; ribavirin (RBV), sofosbuvir (SF) daclatasvir (DAC) were simultaneously determined in human plasma by a validated, simple and sensitive RP-HPLC method using propyl paraben as an internal standard. Liquid–liquid extraction using ethyl acetate was used for samples extraction. Chromatographic separation was achieved on Scharlau® C18 column (250 × 4.6 mm2, 5 μm). Gradient elution was employed with a mobile phase mixture of water and acetonitrile at a flow rate 1 mL/min. UV detection using photodiode array detector was carried out at 207, 260 and 312 nm for RBV, SF and DAC, respectively. Method validation was performed according to the FDA guidelines for bioanalytical method validation. The calibration curves were linear over the ranges (0.5–80, 0.1–40 and 0.5–80 μg/mL) with average recoveries (100.64–108.28%, 98.48–105.91% and 97.68–101.38%) for RBV, SF and DAC, respectively. The intra-day and inter-day precision and accuracy results were within the acceptable limits. Stability assays revealed that the three studied analytes were stable during sample storage, preparation and injection. The method can be successfully applied in routine analysis of plasma of HCV patients treated with this combination therapy which aids in therapeutic drug monitoring and patients’ follow-up especially in Egypt and other developing countries fighting HCV.

Analytical Method Validation of Testosterone Undecanoate Soft Gelatin Capsule by RP-HPLC Method

2018 ◽  
Vol 07 (01) ◽  
Author(s):  
Md Didarul Md Didarul Islam ◽  
Mehedi Hasan M ◽  
Mohiuddin TM ◽  
Md Mynul Hassan ◽  
Asheful Latif ◽  
...  
Keyword(s):  
Method Validation ◽  
Analytical Method ◽  
Hplc Method ◽  
Gelatin Capsule ◽  
Testosterone Undecanoate ◽  
Analytical Method Validation ◽  
Rp Hplc ◽  
Soft Gelatin Capsule

scholarly journals Development and Validation of RP-HPLC Method for Desoximetasone in Bulk and Cream Formulation

2019 ◽  
Vol 9 (3) ◽  
pp. 154-159
Author(s):  
Ashish Gorle ◽  
Jayashri Mahajan ◽  
Prathamesh Bhave
Keyword(s):  
Method Validation ◽  
Mobile Phase ◽  
High Performance ◽  
Gradient Elution ◽  
Hplc Method ◽  
Topical Steroids ◽  
Cream Formulation ◽  
Rp Hplc ◽  
Validation Parameters ◽  
Development And Validation

Desoximetasone chemically is 9-fluoro-IIβ21-dihydroxy-I6a-methylpregna-I.4-diene-3.The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. So, in present investigation chromatographic methods were developing use RP-HPLC for estimation of Desoximetasone in bulk and in cream formulation and method validation according to ICH guidelines. The main objective of this study was to develop a simple and reproducible method for desoximetasone by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). In this work the desoximetasone separation was carried out by using C18 cosmosile column (250mmx4.6mm particle size 5µm). By using 0.1% orthrophosphoric acid pH adjusted up to 3 at uv detection of 240nm.The mobile phase was used at various ratio for gradient elution the ratio of mobile phase was 20:80 v/v. Methanol and water used for mobile phase and flow rate was being set at 1mL/min. The linearity of proposed method was found in range of r =0.9989. Statistically validation parameters such as linearity, accuracy, precision, LOD and LOQ were checked. Keywords: Desoximetasone, RP-HPLC, Method validation.

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.

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