STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE AND HYDROCHLOROTHIAZIDE IN PHARMACEUTICAL DOSAGE FORM
Objective: The aim of present work is to develop a simple, selective and precise, stability indicating RP-HPLC method for the simultaneous estimation of Amlodipine and Hydrochlorothiazide.
Methods: The chromatographic separation of the two drugs was achieved on a reverse phase Hypersil Gold, C18, 250 Ã— 4.6 mm, 5Î¼m column using mobile as Potassium dihydrogen bufferâ€“Acetonitrile in ratio of 600:400 v/v (pH adjusted to 3.2Â±0.05 using orthophosphoric acid) with flow rate of 1.0 ml/min with injection volume 20 Î¼l and the detection was carried out at 237 nm using UV detector.
Results: The retention time of amlodipine (Amlo) and hydrochlorothiazide (HCT) were found to be 3.80 and 6.48 min respectively. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 0.84-1.98 Î¼g/ml for hydrochlorothiazide and 4.2-9.8 Î¼g/ml for amlodipine.
Conclusion: The method was validated for precision, linearity, LOD and LOQ, specificity, accuracy, system suitability and ruggedness as per ICH guidelines and the results were found to be within the limits. The developed method was used for the stability studies. The validated method can be used for routine quality control testing for HCT and Amlo combine dosage form.Keywords: Amlodipine, Hydrochlorothiazide, RP-HPLC, Validation, Stability.
2. British pharmacopeia. Vol 1. Department of Health and social services and public safety, HR stationary office London; 2009. p. 325.
3. Sethi PD. A text book of HPLC Quantitative Analysis of Pharmaceutical Formulations. 1st Edn. New Delhi: CBS Publishers and Distributors; 2001. p. 1-54.
4. Khatija MD, Chapala D, Shrinivas P. Development and validation of RP HPLC method for simultaneous estimation of Amlodipine and hydrochlorothiazide table application to dissolution study. Int Res J Pharm 2013;4:177-80.
5. Boyka G, Tavetkova, Peikova LP. Development and validation of RP HPLC method for simultaneous determination of amlodipine besylate and hydrochlorothiazide, in pharmaceutical dosage. J Chem Pharm Res 2013;5:271-5.
6. Rekulapally VJ, Rao VU. Stability indicating RP HPLC method development and validation for Aliskiren, Amlodipine and hydrochlorothiazide in tablet dosage form. Int J Pharm Pharm Sci 2014;6:724-30.
7. http://www.scribd.com/doc/3848359/Anatical-method-validation and instrument performance verification. [Last accessed on 2015 Jul 15].
8. Ansel C, Nicholas JR. 8th Edn. A text book of Ansel pharmaceutical dosage form and drug delivery system; 2006. p. 124-5.
9. Carstensen JT. A text book of drug stability principles and practice; 1995;68. p. 1-6, 499.
10. Wiliams L, Wilkins. 21th Edn. A text book of Remington the science and practice of pharmacy; 2010. p. 1030-2.