A Novel Stability Indicating RP-HPLC Method Development and Validation for The Simultaneous Estimation of Losartan Potassium, Ramipril and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Form
 
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Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, India
CORRESPONDING AUTHOR
RLC Sasidhar   

Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram, Chandramoulipuram, Guntur, Andhra Pradesh, India
Publication date: 2016-08-07
 
Eurasian J Anal Chem 2016;11(5):255–265
 
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ABSTRACT
A novel stability indicating reverse phase liquid chromatographic method has been developed for the simultaneous estimation of Losartan Potassium, Ramipril and Hydrochlorothiazide in bulk and Pharmaceutical formulations by using reverse phase Kromasil 100-5 C18 column [250mm x 4.6mm].The mobile phase (Methanol: phosphate buffer-pH 4.0) in the ratio of 70:30% v/v was pumped at a flow rate of 0.8ml/min and the column effluents were monitored at 233nm using Variable Wavelength UV detector. Linearity was obtained in the concentration range of 100-500 μg/ml for Losartan Potassium, 10-50 μg/ml for Ramipril and 20-100μg/ml for Hydrochlorothiazide. The established method was statistically validated according to the ICH Q2B guidelines and the percentage relative standard deviation for precision, robustness and ruggedness was found to be less than 2% indicating high degree of precision and robustness. The percentage recovery for the accuracy was found to be 100.76%, 96% and 98% for Losartan Potassium, Ramipril, and Hydrochlorothiazide respectively which were within the specified limits of recovery. Assay for the marketed formulation proved that 100.76% of Losartan Potassium and 96% of Ramipril and 98.22% of Hydrochlorothiazide. The proposed analytical method was observed for various stress condition and it was proved that more stable even under acidic, alkaline, peroxide and thermal degradation conditions. Hence due to its simplicity, rapidity, precision, accuracy and stability the developed HPLC method can be applied for the estimation of Losartan Potassium, Ramipril and ydrochlorothiazide in pure and marketed formulations by a modern analyst.
 
REFERENCES (16)
1.
Beckett AH, Stenlake JB(2002). Practical Pharmaceutical Chemistry, 4th edition, CBS Publishers and Distributors: London, P 157.
 
2.
Kasture AV, Wadodkar SG, Mahadik KR, More HM (2002) Instrumental Methods of Pharmaceutical Analysis, 8th edition, Nirali Prakashan: India, P 156-168.
 
3.
Sharma BK (2004). Instrumental Methods Of Chemical Analysis, 23rd edition, Goel Publishing House: India, P 163-167.
 
4.
Skoog A, Holler FI, Nieman TA (2005). Fundamentals of Analytical Chemistry, 5th edition, Saunders College Publishing: USA, P 673-688.
 
5.
Sreekanth N, Shivshanker K, Shamuga Pandian P, Roosewelt C (2007) Simultaneous Estimation and Validation of Rampiril, Losartan Potassium and Hydrochlorothiazide by RP-HPLC in Pure and Pharmaceutical Dosage Form. Asian journal of chemistry 5: 2850-2856.
 
6.
Ashtosh Kumar S, Manidipa D, Seshagiri Rao JVLN. (2013) Development and validation of stability indicating RP-HPLC method for simultaneous estimation of losartan potassium, ramipril and hydrochlorothiazide in bulk as well as in pharmaceutical formulation. Indo American journal of pharmaceutical research 6: 5423-5443.
 
7.
Dobrina D, Tsvetkova, Danka PO, (2012). Validation of UV – Spectrophotometric Method for Identification and Determination of Angiotensin II Receptor Antagonist Losartan Potassium, International journal of pharmacy and pharmaceutical sciences. 4(1) 428-431.
 
8.
Syed I, Lahoti S, Zahid Z, Mirza S (2012) UV Spectrophotometric methods for estimation of Ramipril in Pharmaceutical dosage form by absorption maxima method and area under curve. International journal of drug development and research 4(1): 286-290.
 
9.
Hapse S A, Wagh VS, Kadaskar PT, Dokhe MD, Shirsath AS(2012) Spectrophotometric estimation and validation of hydrochlorothiazide in tablet dosage forms by using different solvents. Der Pharma Chemica, 4 (1):10-14.
 
10.
Kathiresan K, Gothandaraman S, Swamivel Manickam M, Mathan Kumar S, Manavalan R (2008) Analytical method development and validation of losartan potassium tablet by RP-HPLC. Rasayan Journal of Chemistry 1(3): 521-525.
 
11.
Manju Latha YB, Gowri Sankar D (2012). Isocratic RP-HPLC method development and validation for the simultaneous estimation of ramipril And telmisartan in tablet dosage form. Inventi:PPAQA, 2: 40-45.
 
12.
Ramkumar D, Manik G (2015) Simultaneous Determination and Pharmacokinetic Study of Losartan, Losartan Carboxylic Acid, Ramipril, Ramiprilat, and Hydrochlorothiazide in Rat Plasma by a Liquid Chromatography/Tandem Mass Spectrometry Method. Scientica pharmaceutica. 83: 107–124.
 
13.
K.Srinivas Rao (2011) RP-HPLC method for the determination of losartan potassium and ramipril in combined dosage form. Indian Journal of Pharmaceutical Sciences,72 (1): 108-111.
 
14.
Teli MS, Sawant SS, Patil AR, Ravetkar A, Shirote PJ (2010). Stability indicating LC estimation of ramipril and hydrochlorthiazide in its bulk and tablet formulation. International Journal of Pharmacy And Life Sciences. 1(6) 325-335.
 
15.
ICH, (2003). Stability testing of new drug substances and products. Geneva: International Conference on Harmonization. IFPMA.
 
16.
ICH, Q1A, (1993). Stability Testing of New Drug Substances and Products. In: Proceedings of the International Conference on Harmonisation, Geneva, October.
 
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