Efinaconazole: DoE-supported development and validation of a quantitative HPTLC method and its application for the assay of drugs in solution and microemulsion-based formulations

2020 ◽  
Vol 12 (10) ◽  
pp. 1380-1388 ◽  
Author(s):  
Rashmin B. Patel ◽  
Mrunali R. Patel ◽  
Nikesh R. Patni ◽  
Vikas Agrawal
Keyword(s):  
Pharmaceutical Formulations ◽  
Densitometric Analysis ◽  
Development And Validation ◽  
Hptlc Method

Herein, a simple and rapid HPTLC method using densitometric analysis was developed and validated for the assay of efinaconazole in pharmaceutical formulations (solution and microemulsion).

scholarly journals DEVELOPMENT AND VALIDATION OF A HPTLC METHOD FOR SIMULTANEOUS DENSITOMETRIC ANALYSIS OF GLYCYRRHETIC ACID AND SOLASODINE IN HERBAL DRUG FORMULATION

2017 ◽  
Vol 9 (4) ◽  
pp. 29 ◽  
Author(s):  
Kinjal Patel ◽  
Chaitanya Bhatt
Keyword(s):  
High Performance ◽  
Area Under The Curve ◽  
Retention Factor ◽  
Drug Formulation ◽  
Glycyrrhetic Acid ◽  
Densitometric Analysis ◽  
Polyherbal Formulation ◽  
Quality Control Tool ◽  
Development And Validation ◽  
Hptlc Method

Objective: To develop and validate a simple, precise, selective, and accurate high-performance thin layer chromatographic method for simultaneous densitometric analysis of glycyrrhetic acid and solasodine in the polyherbal formulation.Methods: The method was developed using HPTLC silica gel GF254precoated aluminium plate as the stationary phase and Chloroform: Methanol (9:1 v/v) as the mobile phase. Quantization of glycyrrhetic acid was achieved by determining the area under the curve at 267 nm using CAMAG TLC Scanner and CATS 3 software. Since the structure of solasodine lacks conjugated double bond, it does not give any fluorescence either in the absorbance mode or reflectance mode hence solasodine was derivatized using 0.5%anisaldehyde sulphuric acids which gave a bluish spot as seen on TLC plate. These spots were scanned at 546 nm wavelength using CAMAG TLC Scanner and CATS 3 software.Results: The retention factor for glycyrrhetic acid and solasodine were found to be 0.52±0.01, 0.40±0.01% w/w respectively. The developed HPTLC method was validated using parameters described in International Conference on Harmonization (ICH) guideline. The proposed method showed good linearity in the range of 400-2000 ng spot-1 for glycyrrhetic acid as well as for solasodine. The content of glycyrrhetic acid and solasodine in marketed polyherbal formulation were found to be 0.67%±0.8 and 0.10±0.35%w/w respectively.Conclusion: The developed method can be used as quality control tool for the routine analysis of glycyrrhetic acid and solasodine in polyherbal formulation.

scholarly journals Development and validation of pimavanserin tartrate by normal phase- HPTLC method

2021 ◽  
Vol 8 (2) ◽  
pp. 75-78
Author(s):  
Mohammad Mojeeb Gulzar Khan ◽  
Pawar Vivek Laxman ◽  
Abdul Talib ◽  
Sandip Dinkar Firke ◽  
Mohan G Kalaskar ◽  
...  
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Normal Phase ◽  
Limit Of Quantification ◽  
Label Claim ◽  
Development And Validation ◽  
Layer Chromatography ◽  
Hptlc Method

For the determination of pimvanserin tartrate in bulk and formulation, a rapid and simple High Performance Thin Layer Chromatography at 226 nm was developed and validated. The determination was carried out on thin coated aluminum backing plates covered with 200 mm layer of silica gel G 60 F254 (10×10 cm) plate as stationary phase and using a mobile phase of methanol: chloroform: trimethylamine (4:6:0.1 v/v/v) respectively. With a correlation coefficient (r) of 0.998, the development of pimvanserin tartrate was linear in the range of 0.7 to 4.2 µg/ml. The limit of detection (LOD) was found to be 7.68 ng/spot while the limit of quantification was found to be 23.28 ng/spot. The percentage label claim of pimvanserin tartrate in bulk and formulation was found to be 99 – 101 %. The percentage found in the formulation shows that no effect of excipient on drug. The conducted procedure has the benefit of being simple and quick. As a result, it can be used to examine pimvanserin tartrate in pharmaceutical formulations.

Development of Validated Stability Indicating HPTLC Method for Assay of Ozagrel and its Pharmaceutical Formulations

2018 ◽  
pp. 36-48 ◽  
Author(s):  
Vishal N Kushare ◽  
Sachin S Kushare
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
Pharmaceutical Formulations ◽  
Base Hydrolysis ◽  
Assay Method ◽  
Related Substance ◽  
Stability Indicating ◽  
Regular Production ◽  
Hptlc Method

The present paper describes stability indicating high-performance thin-layer chromatography (HPTLC) assay method for Ozagrel in bulk drugs. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: triethylamine (6.5: 4.0: 0.1 v/v/v). The system was found to give compact spot for Ozagrel (Rf value of 0.40 ± 0.010). Densitometric analysis of Ozagrel was carried out in the absorbance mode at 280 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.999 with respect to peak area in the concentration range 30 - 120 ng/spot. The developed HPTLC method was validated with respect to accuracy, precision, recovery and robustness. Also to determine related substance and assay determination of Ozagrel that can be used to evaluate the quality of regular production samples. The developed method can also be conveniently used for the assay determination of Ozagrel in pharmaceutical formulations. The limits of detection and quantitation were 4.069 and 12.332 ng/spot, respectively by height. Ozagrel was subjected to acid and alkali hydrolysis, oxidation, photochemical and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of Ozagrel in bulk drug and tablet formulation.

Sign in / Sign up

Export Citation Format

Share Document