Development and validation of a stability-indicating HPTLC method for the determination of mirtazapine as bulk drug and in pharmaceutical formulation

2012 ◽  
Vol 25 (1) ◽  
pp. 72-76
Author(s):  
Laxman Potale ◽  
Amol Khodke ◽  
Shangiresh Patole ◽  
Mrinalini Damle
Keyword(s):  
Pharmaceutical Formulation ◽  
Stability Indicating ◽  
Bulk Drug ◽  
Development And Validation ◽  
Hptlc Method

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF APIXABAN AS BULK DRUG

2019 ◽  
pp. 37-42
Author(s):  
Mrinalini C. Damle ◽  
Swapnil S Waghmare ◽  
PURUSHOTAM SINHA
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Limit Of Detection ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Chromatographic Condition ◽  
Bulk Drug ◽  
Development And Validation ◽  
Hptlc Method

Objective: To develop and validate simple, sensitive stability indicating HPTLC (High performance thin layer chromatography) method for apixaban. Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using toluene: ethyl acetate: methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm. Results: The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0.03. Stress testing was carried out according to international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines. The calibration curve was found to be linear in the concentration range of 100-500 ng/band for apixaban. The limit of detection and quantification was found to be 11.66ng/bandand35.33ng/band, respectively. Conclusion: A new simple, sensitive, stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of apixaban.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SWERTIAMARIN IN BULK AND DOSAGE FORM

2017 ◽  
Vol 9 (6) ◽  
pp. 80
Author(s):  
H. Padh ◽  
S. Parmar ◽  
B. Patel
Keyword(s):  
High Performance ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Bulk Drug ◽  
Development And Validation ◽  
Layer Chromatography ◽  
Herbal Formulations ◽  
Hptlc Method ◽  
Ich Guideline

Objective: In the present study a novel stability-indicating high-performance thin-layer chromatography (HPTLC) method for quantitative determination of Swertiamarin (SW) in bulk drug and formulation has been developed and validated as per ICH guideline Q2 (R1) for global acceptance of standardized herbal formulations.Methods: HPTLC method is developed and validated using solvent ethyl acetate: ethanol: chloroform (3:2.5:4.5 v/v/v) (Rf of SW 0.65±0.04) in the absorbance mode at 243 nm. Various forced degradation conditions were used to check degradation of drug.Results: The method showed a good linear relationship (r2 = 0.9990) in the concentration range 200-700 ng per spot. It was found to be linear, accurate, precise and specific.Conclusion: It can be applied for quality control as well as for stability testing of different dosage forms containing swertiamarin. The developed method is validated as per ICH guideline Q2(R1) for global acceptance of standardized herbal formulations.

scholarly journals Development and Validation of Stability Indicating HPTLC Method for Determination of Diacerein and Aceclofenac as Bulk Drug and in Tablet Dosage Form

2012 ◽  
Vol 9 (4) ◽  
pp. 2023-2028 ◽  
Author(s):  
S. P. Gandhi ◽  
M. G. Dewani ◽  
T. C. Borole ◽  
M. C. Damle
Keyword(s):  
Assay Method ◽  
Stability Indicating ◽  
Dry Heat ◽  
Wet Heat ◽  
Anti Inflammatory ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Hptlc Method

Diacerein is a drug for osteoarthritis and is di-acetylated derivative of rein. Aceclofenac is used as an effective non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic properties. The present study describes degradation of diacerein and aceclofenac under ICH prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat, and photolysis) and establishment of a stability-indicating HPTLC assay method. Different degradation peaks were observed for diacerein when it was exposed to alkaline, and acid catalysed hydrolysis. For aceclofenac, decrease in peak area was observed with single peak of degradation product after oxidation. For HPTLC, RP-18 F254spre-coated plates, and mobile phase consisting of methanol: water 7: 3 v/v was used to achieve separation. Quantitation was done at 268 nm. The method was validated as per ICH Q2 R1 guidelines and results were in limit. The method was found to be simple, specific, precise, and stability indicating.

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