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Development of validated stability-indicating analytical method for simultaneous estimation of Atenolol and Hydrochlorothiazide in pharmaceutical combined dosage form by High Performance Thin Layer Chromatography.
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| Author:
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SUNIL SHEWALE, SAMEER PAREKH, PRAMOD PUJARI
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| Abstract:
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Objective: To develop a validated stability-indicating analytical method for simultaneous estimation of Atenolol (ATN) and Hydrochlorothiazide (HTZ) in pharmaceutical combined dosage form by HPTLC.
Method: A high performance thin layer chromatographic (HPTLC) method has been developed for the separation of ATN and HTZ on plates precoated with aluminium back silica gel 60 F254. Different mobile phases were used on trial and error basis for separation of two drugs. The final mobile phase selected for analysis was n-butanol: ethyl acetate: methanol: tetrahydrofuran in the ratio (1:2:2:1 v/v). Both the drugs showed maximum absorbance at 250 nm which was selected as the detection wavelength throughout the experimental work. Developed method was validated as per ICH guidelines. Forced degradation of drugs was carried out under various stress conditions and HPTLC method was used for analysing the stability of drugs.
Result: HPTLC method was successfully developed for separation of ATN and HTZ with good resolution. Method validation after assessment of various parameters indicated low % RSD within an acceptable limit of < 2.0 and the stability studies indicated the separation of both the drugs from that of degraded products with acceptable % drug recovery profile.
Conclusion: The developed method is rapid, reliable, precise, and reproducible and demonstrates the suitability of the method for stability determination of atenolol and hydrochlorothiazide.
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| Keyword:
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Atenolol, Hydrochlorothiazide, Stability indicating method, HPTLC
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| DOI:
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