A New HPTLC Method for Analysis of Artemisinin Derivatives (Artemether and Lumefantrine) in Bulk Drug and Liposomal Formulation: Stress Degradation Study

2020 ◽  
Vol 11 (1) ◽  
pp. 13-20
Author(s):  
Akhlaquer Rahman ◽  
Ranjit Kumar Harwansh ◽  
Kashif Shakeel
Keyword(s):  
Liposomal Formulation ◽  
Degradation Study ◽  
Artemisinin Derivatives ◽  
Stress Degradation ◽  
Bulk Drug ◽  
Hptlc Method

HPTLC METHOD FOR ANALYSIS OF SERTRALINE IN PURE BULK DRUG AND LIPIDIC NANO DELIVERY SYSTEM: A STRESS DEGRADATION STUDIES

2013 ◽  
Vol 36 (6) ◽  
pp. 700-716
Author(s):  
Arshad Hussain ◽  
Md. Akhlaquer Rahman ◽  
Md. Sarfaraj Hussain ◽  
Mohd. Aamir Mirza ◽  
Zeenat Iqbal ◽  
...  
Keyword(s):  
Delivery System ◽  
System A ◽  
Stress Degradation ◽  
Degradation Studies ◽  
Bulk Drug ◽  
Hptlc Method

Development and Validation of a Stability-Indicating HPTLC Method for the Estimation of Eszopiclone in Pharmaceutical Dosage Forms

2021 ◽  
Vol 11 (3) ◽  
pp. 219-223
Author(s):  
Vidhya K. Bhusari ◽  
Sunil R. Dhaneshwar
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Limit Of Detection ◽  
Degradation Products ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Limit Of Quantitation ◽  
Stress Degradation ◽  
Bulk Drug ◽  
Hptlc Method

Objective: A simple, sensitive, selective, precise repeatable and stability-indicating high-performance thin layer chromatographic method was developed and validated for Eszopiclone in bulk drug and in formulation. Method: Silica gel 60 F-254, TLC precoated aluminium plates was used as the stationary phase for analyzing Eszopiclone and its degradation products, using mobile phase consisting toluene: ethyl acetate: methanol (6: 4: 2 v/v/v). Result: This mobile phase gave compact spots for Eszopiclone with Rf value of 0.52 ± 0.02. Eszopiclone was exposed to hydrolysis, oxidation, neutral and photolytic conditions for conducting stress degradation study. The peak of Eszopiclone and the degradation product was well resolved from each other with a significantly different Rf value. Densitometric estimation of Eszopiclone was performed at 304nm. A good linear plot was obtained in the concentration range of 150-300ng/spot. The method was validated for precision, accuracy (recovery) and robustness study. The limit of detection (LOD) and limit of quantitation (LOQ) was found to be 130ng/spot and 150ng/spot, respectively. Conclusion: The developed HPTLC method can separate Eszopiclone from its degradation products, hence stability studies can be performed using this method.

Development and Validation of Stability Indicating HPTLC Method for Estimation of Salmeterol Xinafoate

2019 ◽  
Vol 10 (01) ◽  
Author(s):  
Damle M ◽  
Choudhari S
Keyword(s):  
Quantitative Estimation ◽  
Degradation Study ◽  
Stability Indicating ◽  
Salmeterol Xinafoate ◽  
Ich Guidelines ◽  
Stress Degradation ◽  
Aluminium Sheets ◽  
Development And Validation ◽  
Chloroform Methanol ◽  
Hptlc Method

A simple, rapid validated stability indicating HPTLC method for estimation of Salmeterol xinafoate was successfully developed. This method is based on HPTLC separation followed by UV detection at 252 nm. The separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 using Chloroform: Methanol: Ammonia (7:3:0.5 v/v/v) as a mobile phase and scanning was done by using TLC Scanner III. Salmeterol xinafoate gave well defined and sharp peak at Rf 0.52 ± 0.05 at 252 nm. Calibration curve was linear in range 1000-3000 ng/band for Salmeterol xinafoate. Stress degradation study includes hydrolysis under different pH, oxidation, thermal and photolytic conditions. The suitability of this HPTLC method for quantitative estimation of Salmeterol xinafoate was proved by validation in accordance with requirements of ICH guidelines Q2A (R1).

scholarly journals Quality risk assessment and DoE – Practiced validated stability-indicating chromatographic method for quantification of Rivaroxaban in bulk and tablet dosage form

2022 ◽  
Keyword(s):  
Method Development ◽  
Quadratic Model ◽  
Forced Degradation ◽  
Linear Calibration ◽  
Pareto Chart ◽  
Degradation Study ◽  
Saturation Time ◽  
Stability Indicating ◽  
Stress Degradation ◽  
Hptlc Method

Abstract A systematic DoE and Analytical Quality by Design (AQbD) approach was utilized for the development and validation of a novel stability indicating high-performance thin–layer chromatographic (HPTLC) method for Rivaroxaban (RBN) estimation in bulk and marketed formulation. A D-optimal design was used to screen the effect of solvents, volume of solvents, time from spotting to development and time for development to scanning. ANOVA results and Pareto chart revealed that toluene, methanol, water and saturation time had an impact on retention time. The critical method and material attributes were further screened by Box-Behnken design (BBD) to achieve optimal chromatographic condition. A stress degradation study was carried out and structure of major alkaline degradant was elaborated. According to the design space, a control strategy was used with toluene: methanol: water (6:2:2) and the saturation time was 15 min. A retention factor (RF) of 0.59 ± 0.05 was achieved for RBN using chromatographic plate precoated with silica gel at detection wavelength 282 nm with optimized conditions. The linear calibration curve was achieved in the concentration range of 200–1,200 ng/band with r 2 > 0.998 suggesting good coordination between analyte concentration and peak areas. The quadratic model was demonstrated as the best fit model and no interaction was noted between CMAs. The optimized HPTLC method was validated critically as stated in International Conference on Harmonization (ICH) Q2 (R1) guideline and implemented successfully for stress degradation study of RBN. The developed HPTLC method obtained through AQbD application was potentially able to resolve all degradants of RBN achieved through forced degradation study. The obtained results demonstrate that a scientific AQbD approach implementation in HPTLC method development and stress degradation study drastically minimizes the number of trials in experiments, ultimately time and cost of analysis could be minimized.

HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE FROM BULK AND IT'S ORAL FORMULATION

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (02) ◽  
pp. 53-61
Author(s):  
A Shirode ◽  
◽  
A. Nath ◽  
V. Kadam
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Oral Formulation ◽  
Control Analysis ◽  
Uv Detector ◽  
Analytical Method Validation ◽  
Starting Position ◽  
Hydrochloride Monohydrate ◽  
Bulk Drug ◽  
Hptlc Method

A simple and selective high performance thin layer chromatographic (HPTLC) method was developed and validated for the estimation of ziprasidone hydrochloride monohydrate (ZHM) from its marketed formulation and oral formulation. The CAMAG HPTLC system, operated with software winCATS (ver.1.4.1.8) was used for proposed analytical work. Planar chromatographic development was carried out with the help of silica gel 60 F254 precoated aluminium TLC plates. Sample application was employed using Linomat 5 applicator. The optimized mobile phase was composed of toluene: glacial acetic acid: methanol (6: 0.3: 3 V/V/V). The detection of spots was carried out densitometrically using a UV detector at 317nm in absorbance mode. In HPTLC densitogram well defined peak was obtained for ZHM with starting position at 59 hRf, max position at 63 hRf and end position at 65 hRf. The optimum hRf value for ZHM was found to be 63. Performance characteristics of HPTLC method for estimation of ZHM in bulk drug and its marketed dosage form were statistically validated as per recommendations of ICH guidelines of analytical method validation. The HPTLC method was found to be linear across the range 20-140 ng/band. The LOD and LOQ values were found to be 13.573 and 41.130 ng/band, respectively. The method was found to be accurate, precise, robust and economical for the analysis of ZHM from bulk drug and its formulation. The proposed analytical HPTLC method can be used for routine quality-control analysis of ZHM.

Sign in / Sign up

Export Citation Format

Share Document