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Sci. Pharm.
Volume 79
Issue 2
10.3797/scipharm.1101-06
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Article

A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form

by
Nitish SHARMA
1,2,*,
Surendra Singh RAO
1,
Pingili Sunil REDDY
1 and
Annarapu MALLESWARA REDDY
1
1
Analytical Research and Development, IPDO, Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad500072, A.P, India
2
Department of chemistry, J. N. T. University, Kukatpally, Hyderabad-85, A.P, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2011, 79(2), 309-322; https://doi.org/10.3797/scipharm.1101-06
Submission received: 6 January 2011 / Accepted: 10 February 2011 / Published: 12 February 2011
Versions Notes

Abstract

A selective, specific and stability-indicating gradient reverse phase highperformance 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: Method development; Stability-indicating; Ranitidine; Stress conditions; Impurities; Oral Solution; RP-HPLC Method development; Stability-indicating; Ranitidine; Stress conditions; Impurities; Oral Solution; RP-HPLC

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MDPI and ACS Style

SHARMA, N.; Singh RAO, S.; REDDY, P.S.; MALLESWARA REDDY, A. A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form. Sci. Pharm. 2011, 79, 309-322. https://doi.org/10.3797/scipharm.1101-06

AMA Style

SHARMA N, Singh RAO S, REDDY PS, MALLESWARA REDDY A. A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form. Scientia Pharmaceutica. 2011; 79(2):309-322. https://doi.org/10.3797/scipharm.1101-06

Chicago/Turabian Style

SHARMA, Nitish, Surendra Singh RAO, Pingili Sunil REDDY, and Annarapu MALLESWARA REDDY. 2011. "A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form" Scientia Pharmaceutica 79, no. 2: 309-322. https://doi.org/10.3797/scipharm.1101-06

APA Style

SHARMA, N., Singh RAO, S., REDDY, P. S., & MALLESWARA REDDY, A. (2011). A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form. Scientia Pharmaceutica, 79(2), 309-322. https://doi.org/10.3797/scipharm.1101-06

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