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HPTLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CHLORTHALIDONE AND IRBESARTAN IN COMBINED TABLET DOSAGE FORM

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A simple, accurate and rapid high performance thin layer chromatography (HPTLC)-densitometry method was developed for separation and determination of chlorthalidone (CHL) and irbesartan (IBS) in pharmaceutical dosage forms. The compounds were separated on silica gel 60 GF254, HPTLC plates using mobile phase of toluene: ethyl acetate: acetonitrile: methanol: ammonia solution (25%) [5:2:2:1:0.2 v/v/v/v] as compact spots at Rf of 0.57 for chlorthalidone and Rf of 0.36 for irbesartan. Densitometric detection was performed at 254 nm. The method was validated in terms of linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves were linear in the range of 12.5-75 ng/spot for CHL and 150-900ng/spot for IBS. For CHL recovery varied in range of 99.26-101.25% and for IBS recovery varied in range of 99.76-100.40%. The LOD was found 1.33 and 11.34 ng/spot for CHL and IBS respectively. The LOQ was found 4.03 and 14.37 ng /spot for CHL and IBS respectively. It was observed that the proposed HPTLC method could be used for efficient analysis of the CHL and IBS in combined tablet dosage forms.
Indian Drug Manufacturers' Association (IDMA)
Title: HPTLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CHLORTHALIDONE AND IRBESARTAN IN COMBINED TABLET DOSAGE FORM
Description:
A simple, accurate and rapid high performance thin layer chromatography (HPTLC)-densitometry method was developed for separation and determination of chlorthalidone (CHL) and irbesartan (IBS) in pharmaceutical dosage forms.
The compounds were separated on silica gel 60 GF254, HPTLC plates using mobile phase of toluene: ethyl acetate: acetonitrile: methanol: ammonia solution (25%) [5:2:2:1:0.
2 v/v/v/v] as compact spots at Rf of 0.
57 for chlorthalidone and Rf of 0.
36 for irbesartan.
Densitometric detection was performed at 254 nm.
The method was validated in terms of linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ).
The calibration curves were linear in the range of 12.
5-75 ng/spot for CHL and 150-900ng/spot for IBS.
For CHL recovery varied in range of 99.
26-101.
25% and for IBS recovery varied in range of 99.
76-100.
40%.
The LOD was found 1.
33 and 11.
34 ng/spot for CHL and IBS respectively.
The LOQ was found 4.
03 and 14.
37 ng /spot for CHL and IBS respectively.
It was observed that the proposed HPTLC method could be used for efficient analysis of the CHL and IBS in combined tablet dosage forms.

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