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Abstract
A sensitive, selective, precise, and stability-indicating, high-performance, thin-layer chromatographic (HPTLC) method for analysis of sertraline, both as a bulk drug and in house formulation, was developed and validated. The method employed thin-layer chromatographic (TLC) aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of Toulene/Ethyl acetate/Ammonia (1:5:0.1, v/v) as a mobile phase. The densitometric analysis were carried out at 273 nm using Camag TLC scanner which generated compact spots for SRT (R f = 0.70 ± 0.02). The linear regression data for the calibration plots showed good linear relationship with r2 = 0.998 in the concentration range of 25–2000 ng spot−1. Sertraline was subjected to acid and alkali hydrolysis, oxidation, photodegradation, and dry heat treatment. Also, the degraded products were well separated from the pure drug. The method was validated for precision, accuracy, ruggedness, and recovery. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one. Moreover, the proposed HPTLC method was utilized to investigate the kinetics of acid and base degradation process.
ACKNOWLEDGMENT
Md. A. Rahman is highly grateful to the Indian Council of Medical Research (ICMR), Government of India for approval of the project to provide financial assistance in the form of senior research fellowship (SRF). The authors are also thankful to R&D division, Ranbaxy, Gurgaon (India) for providing the gift sample of the drug.
Notes
a = Degradation rate constant.
b = half-life.
c = shelf-life (time left for 90% potency).