VALIDATED STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR REPAGLINIDE API

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (09) ◽  
pp. 48-54
Author(s):  
P. P. Thakkar ◽  
◽  
N. R Patel ◽  
C. S Kothari ◽  
R Patel ◽  
...  
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Linear Regression Analysis ◽  
Tablet Formulation ◽  
Content Uniformity ◽  
Calibration Data ◽  
Stability Indicating ◽  
Photolytic Degradation

A simple, precise and accurate stability-indicating high performance thin layer chromatographic method for estimation of repaglinide in bulk drug and in tablet formulation has been developed and validated. The stationary phase used was HPTLC plates precoated with silica gel 60F254 using the mobile phase of chloroform: methanol: ammonia (4.5:1.0:0.05 V/V/V). Densitometric analysis was performed in absorbance mode at 242 nm. The method showed compact bands of drug at RF value of 0.31 ± 0.02. Linear Regression analysis of calibration data showed good linear relationship with r2= 0.9981 in concentration range of 500 - 3000 ng/band. Drug was subjected to ICH-prescribed stress conditions such as acid, base, peroxide, thermal and photolytic degradation and method was found able to separate the peaks for all degradation products from analyte peak. Validation of the developed method was carried out for its specificity, linearity, range, precision, accuracy and robustness. The method was further applied for repaglinide estimation in pharmaceutical tablet formulation and it was found to be reliable. The method was also used successfully to carry out content uniformity test of repaglinide in tablet dosage form.

scholarly journals Stability indicating thin-layer chromatographic method for estimation of antidiabetic drug Remogliflozin etabonate

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Dimal A. Shah ◽  
Ishita I. Gondalia ◽  
Vandana B. Patel ◽  
Ashok Mahajan ◽  
Usmangani Chhalotiya ◽  
...  
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Chromatographic Method ◽  
Tablet Formulation ◽  
Base Hydrolysis ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Remogliflozin Etabonate

Abstract Background A sensitive, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the analysis of Remogliflozin etabonate in tablet formulation. HPTLC plates precoated with silica gel 60 F254 were used as the stationary phase; methanol: ethyl acetate: toluene: NH3 (2:4:4:0.1, v/v/v) was used as mobile phase, and densitometry was used for the quantitative estimation of the drug. The proposed method was validated with respect to linearity, accuracy, precision, and robustness and applied for the estimation of drug in tablet dosage form. Results The Rf value of Remogliflozin etabonate was observed to be 0.61. The densitometric estimation was performed in reflectance mode at 229 nm. The method was found to be linear in the range of 500–8000 ng/band for Remogliflozin etabonate. The possible degradation pathway was estimated by performing forced degradation studies. The degradant peaks were well resolved from the drug peak with acceptable resolution in their Rf value. Conclusion An accurate and precise high-performance thin-layer chromatographic method has been developed for the quantification of Remogliflozin etabonate in tablets. Forced degradation studies were performed, and drug was found to be highly susceptible to acid, base hydrolysis, and oxidative stress degradation and gets converted into active drug Remogliflozin. Both Remogliflozin etabonate and Remogliflozin bands were well resolved. The method was applied for the analysis of drug in tablet formulation, and it can be used for routine quality control analysis, as well as for the analysis of stability samples.

scholarly journals Validated Stability Indicating HPTLC Method for the Determination of Dutasteride in Pharmaceutical Dosage Forms

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Dipti B. Patel ◽  
Natubhai J. Patel ◽  
Sejal K. Patel ◽  
Paresh U. Patel
Keyword(s):  
Thin Layer ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Linear Regression Analysis ◽  
Solvent System ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Wet Heat ◽  
Pure Drug

This paper describes simple, sensitive, precise, specific, and stability-indicating high-performance thin-layer chromatographic method for the determination of dutasteride (DUTA) in bulk and tablet formulation. Validation was carried out in compliance with International Conference on Harmonization guidelines. The thin-layer chromatographic method employed aluminium plates precoated with silica gel G60F254 as stationary phase. The solvent system consisted of toluene/methanol/triethylamine (9 : 2 : 1, v/v/v). This solvent system was found to give compact spots for dutasteride with value 0.71 ± 0.01. Densitometric analysis of DUTA was carried out in the absorbance mode at 274 nm. Linear regression analysis showed good linearity () with respect to peak area in the concentration range of 200–3000 ng per spot. The method was validated for precision, accuracy, specificity, and robustness. Pure drug was subjected to acid and alkali hydrolysis, oxidation, photo degradation, dry heat and wet heat treatment. The drug underwent degradation under acidic, basic, oxidative, and wet heat conditions. The degraded products were well separated from the pure drug. Statistical analysis proved that the method is reproducible and selective for estimation of DUTA in bulk and tablets. As the method could effectively separate the drugs from their degradation products, it can be employed as a stability indicating method.

STRESS DEGRADATION STUDIES ON HYDROCHLOROTHIAZIDE AND LISINOPRIL USING VALIDATED STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (04) ◽  
pp. 53-60
Author(s):  
K. G Patel ◽  
H. G. Rana ◽  
N. N Mistry ◽  
T. R Gandhi ◽  
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Phase System ◽  
Standard Drug ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Stress Degradation ◽  
Acidic Degradation

A specific stability indicating high-performance thin-layer chromatographic method for analysis of hydrochlorothiazide and lisinopril in formulations was developed and validated. The method employed precoated silica gel 60F254 HPTLC as the stationary phase. The optimized mobile phase system consisted of acetic acid: methanol: toluene (4:3:8, V/V/V), that gave compact spots for lisinopril and hydrochlorothiazide at Rf of 0.29 and 0.68, at 220 nm, respectively. The drugs were subjected to various accelerated conditions. The peaks of degraded products under various accelerated conditions were well resolved from the peak of standard drug with different Rf values and drug was more susceptible to acidic degradation. Linear relationship was found in the range of 800–1800 and 800-2300ng/band for hydrochlorothiazide and lisinopril respectively. Various parameters were validated as per ICH guideline. Moreover, the method could effectively separate the drug from its degradation products; hence it can be employed as a stability indicating method.

Stability Indicating HPTLC Method for Simultaneous Determination of Amlodipine Besylate and Lisinopril in Combined Dose Tablet Formulation

2021 ◽  
pp. 6250-6256
Author(s):  
Sagar B. Wankhede ◽  
Deepak S. Khobragade ◽  
Sukeshini B. Lote ◽  
S. Patil
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Degradation Products ◽  
Cost Effective ◽  
Tablet Formulation ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Stability Indicating ◽  
Limit Of Quantitation ◽  
Dose Tablet

A combined dose tablet formulation containing Amlodipine besylate and Lisinopril is used for the treatment of essential hypertension. The present study reports development and validation of stability indicating high performance thin layer chromatographic method for simultaneous estimation of these drugs in combined dose tablet formulation. The two drugs were satisfactorily resolved on aluminum plates precoated with silica gel 60F254 using n-butanol : methanol: ammonia (4:4:1 v/v/v) as mobile phase. The Rf value for lisinopril and amlodipine besylate were 0.27±0.02 and 0.62±0.02, respectively. Densitometric evaluation of the separated bands was performed at 215nm. The calibration curves for lisinopril and amlodipine besylate were found to be linear in the concentration range of 1000-6000ng/band. The method was validated as per ICH guidelines for accuracy, precision, robustness, specificity, limit of detection and limit of quantitation. Statistical analysis proves that the method is suitable for simultaneous analysis of Lisinopril and Amlodipine besylate in pharmaceutical formulation without any interference from the excipients/degradant. The developed method offers several advantages such as sensitive, rapid, cost effective and less time consuming as compared to the reported methods. As the method could effectively separate the drugs from its degradation products, it can be employed as a stability indicating method.

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