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A Stability-Indicating HPTLC Method for Estimation of Nadifloxacin in Topical Cream


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1 Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, Maharahtra, India
     

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The present work describes a stability-indicating HPTLC method for analysis of nadifloxacin in topical cream. The separation was carried out on Merck precoated silica gel aluminium plate 60 F254 using Chloroform: Methanol: Ammonia (4.3: 4.3: 1.4 v/v/v) as mobile phase. The densitometric scanning was carried out at 296 nm. Response was found to be linear in the concentration range of 50-300 ng /band with correlation coefficients (r2 = 0.9979). The method was validated as per ICH guidelines. The method was successfully applied for the analysis of drugs in pharmaceutical formulation. Nadifloxacin was subjected to forced degradation by acid, alkali, neutral, oxidation, dry heat, wet heat, sunlight, UV light. The degradation products were well resolved from the pure drug with significantly different RF values.

Keywords

Nadifloxacin, HPTLC, Validation, Stability Studies.
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  • A Stability-Indicating HPTLC Method for Estimation of Nadifloxacin in Topical Cream

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Authors

Rabindra K. Nanda
Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, Maharahtra, India
Amol A. Kulkarni
Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, Maharahtra, India
Meenal N. Ranjane
Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, Maharahtra, India
Poonam N. Ranjane
Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, Maharahtra, India

Abstract


The present work describes a stability-indicating HPTLC method for analysis of nadifloxacin in topical cream. The separation was carried out on Merck precoated silica gel aluminium plate 60 F254 using Chloroform: Methanol: Ammonia (4.3: 4.3: 1.4 v/v/v) as mobile phase. The densitometric scanning was carried out at 296 nm. Response was found to be linear in the concentration range of 50-300 ng /band with correlation coefficients (r2 = 0.9979). The method was validated as per ICH guidelines. The method was successfully applied for the analysis of drugs in pharmaceutical formulation. Nadifloxacin was subjected to forced degradation by acid, alkali, neutral, oxidation, dry heat, wet heat, sunlight, UV light. The degradation products were well resolved from the pure drug with significantly different RF values.

Keywords


Nadifloxacin, HPTLC, Validation, Stability Studies.