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. 2011 Apr-Jun;79(2):309-22.
doi: 10.3797/scipharm.1101-06. Epub 2011 Feb 12.

A validated stability-indicating liquid-chromatographic method for ranitidine hydrochloride in liquid oral dosage form

Nitish Sharma  1 , Surendra Singh Rao, Namala Durga Atchuta Kumar, Pingili Sunil Reddy, Annarapu Malleswara Reddy
Affiliations

A validated stability-indicating liquid-chromatographic method for ranitidine hydrochloride in liquid oral dosage form

Nitish Sharma et al. Sci Pharm. 2011 Apr-Jun.

Abstract

A selective, specific and stability-indicating gradient reverse phase high-performance liquid chromatographic (HPLC) method was developed for the determination of Ranitidine in presence of its impurities, forced degradation products and placebo substances such as saccharide and parabens. Ultraviolet detection was performed at 230 nm. Separate portions of the drug product and ingredients were exposed to stress conditions to induce oxidative, acidic, basic, hydrolytic, thermal and photolytic degradation. Ranitidine was found to degrade significantly at acidic, basic and oxidative stress conditions but was stable at heat and humidity. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. The method was validated over this range for (i) system suitability (ii) specificity, (iii) precision, (iv) limit of detection and limit of quantification, (v) linearity, (vi) accuracy, (vii) robustness. The method was found to be precise, accurate, linear and robust. The proposed method was successfully employed for estimation of Ranitidine impurities in pharmaceutical preparations.

Keywords: Impurities; Method development; Oral Solution; RP-HPLC; Ranitidine; Stability-indicating; Stress conditions.

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Figures

Fig. 1.
Fig. 1.
Chemical structure of Ranitidine HCl and its officinal impurities (USP 31)
Fig. 2.
Fig. 2.
Typical chromatograms of ranitidine from method development trails
Fig. 3.
Fig. 3.
Typical chromatograms of Ranitidine Oral Solution at optimized chromatographic conditions
Fig. 3.
Fig. 3.
Typical chromatograms of Ranitidine Oral Solution at optimized chromatographic conditions
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