DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPTLC METHOD FOR THE ESTIMATION OF OLOPATADINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Abstract
Objective: The present study aimed to develop and validate a simple, precise, accurate, sensitive, and stability-indicating high-performance thin-layer chromatography (HPTLC) method for the quantitative estimation of olopatadine hydrochloride in bulk drug and pharmaceutical dosage forms. Methods: Chromatographic separation was performed on precoated silica gel 60 F254 aluminium plates using chloroform: methanol:glacial acetic acid (8:1:1, v/v/v) as the mobile phase. The chromatographic chamber was saturated for 15 min before plate development, and densitometric detection was carried out at 304 nm using a CAMAG TLC Scanner 3. The method was validated according to International Council for Harmonization Q2(R1) guidelines for linearity, precision, accuracy, robustness, specificity, limit of detection (LOD), and limit of quantification (LOQ). The stability-indicating capability of the method was evaluated through forced degradation studies under acidic, alkaline, oxidative, thermal, neutral, and photolytic stress conditions. Results: The developed method produced a compact and well-resolved peak for olopatadine hydrochloride at a retention factor value of 0.48±0.02. The method exhibited excellent linearity over the concentration range of 500–3000 ng/spot with a correlation coefficient (R2) of 0.9992. The percentage relative standard deviation values for intra-day and inter-day precision were <2%, demonstrating good precision, while the percentage recovery ranged from 99.44% to 100.83%, confirming the accuracy of the method. The LOD and LOQ were found to be 2.55 ng/band and 7.74 ng/band, respectively. Forced degradation studies showed degradation ranging from 7.36% to 19.14% under different stress conditions and the developed method successfully separated the parent drug from its degradation products, confirming its stability-indicating capability. Conclusion: The proposed HPTLC method is simple, rapid, accurate, precise, sensitive, economical, and stability-indicating. It is suitable for routine quality control analysis and stability assessment of olopatadine hydrochloride in bulk drug and pharmaceutical dosage forms.