Development and Validation of RP-HPLC Method for Simultaneous Estimation of Naproxen and Esomeprazole in Pharmaceutical Dosage Form

 

Haritha Gali¹, Vishwanadham Yerragunta²*

¹Department of Pharmaceutical Analysis, PNR College of Pharmacy, Shamshabad, RR Dt., Telangana, India.

²Department of Pharmaceutical Chemistry, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Medak Dt, Telangana, India.

*Corresponding Author E-mail: haritha.shyam1@gmail.com

The objective of the study was to develop a simple, accurate, precise RP-HPLC method for the determination of Esomeprazole and Naproxen using mobile phase (A mixture of Acetonitrile and Methanol in the ratio of 60:40 was considered to be the optimal composition of solvent) as the solvent. The proposed method was involves the measurement of retention time at selected analytical wavelength 260.0 nm was selected as the analytical wavelength. The retention time of Esomeprazole and Naproxen was found to be 3.425 and 4.352. The linearity of the proposed method was in the range of r = 0.9999 for Esomeprazole and r = 0.9999 for Naproxen. The method was statistically validated for its linearity, accuracy and precision of the formulation.

 

 

 

1. INTRODUCTION:

The drug analysis plays an important role in the development, manufacture and therapeutic use of drug. Standard analytical procedure for newer drugs or formulation may not be available in pharmacopoeias, it is essential for the develop a newer analytical methods which are accurate, precise, specific, linear, simple and rapid. Many studies have been reported for the determination of Esomeprazole and Naproxen in Pharmaceutical formulations.

 

Naproxen is chemically designed as (2S)-2-(6-methoxynaphthalen-2-yl) propanoic acid Naproxen is used as Anti inflammatory and analgesic drug and Esomeprazole is a chemically bis (5-methoxy-2-[(S)-[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazol-1-yl) a compound that inhibits gastric acid secretion. Esomeprazole is cost effective in the treatment of gastric esophageal reflux diseases.

 

2. DRUG PROFILE:

2.1. Esomeprazole

 

2.1.1. Structure:

                                           

2.1.2. Chemical name: 5-methoxy-2-{(S)-[(4-methoxy-3, 5-dimethyl-2-   

Pyridinyl) methyl] sulfinyl} benzimidazole.                             

 

2.1.3. Molecular formulae : C₁₇H₁₉N₃O₃S

 

2.1.4. Molecular Weight : 345.4

 

Naproxen:

2.2.1. Structure:

 

2.2.2. Chemical name: (2S)-2-(6-methoxynaphthalen-2-yl)propanoic acid

 

2.2.3. Molecular formulae: C₁₄H₁₄O₃

 

2.2.4. Molecular Weight:  230.3

 

3. METHOD VALIDATION SUMMARY:

3.1    Chemicals and reagents:

The working standards of Esomeprazole and Naproxen were gifted from Pharma Tech labs, Hyderabad. Acetonitrile and Methanol (HPLC grade) were obtained from E. Merck Ltd Mumbai, India.

 

3.2    Instrument used:

A Shimadzu VP series,   pH meter Adwa – AD 1020.

 

3.3    Preparation of standard solution:

Esomeprazole 100 mg and 100mg Naproxen were weighed separately and transferred in two different volumetric flasks. Both the drugs were dissolved in 50 ml of mobile phase by ultrasonication and then volume was made up to the mark with mobile phase to obtain final concentration of 1000 µg/ml of each component.

 

3.4      Preparation of Mobile phase:

Mobile phase was prepared by mixing 600 ml of the HPLC grade Acetonitrile with 400 ml of the HPLC grade and Methanol, filtered through 0.4 µm membrane filter paper and ultrasonicated for 20 min for mobile phase preparation.

 

3.5    Chromatographic condition:

In the mobile phase containing Methanol and Acetonitrile whose ratio was 40:60 was selected as the optimum composition of mobile phase, because it was found that this solvent system Esomeprazole both the components ideally. The flow rate was set to 1.0 ml/min and UV detection was carried out at 260 nm.

 

3.6    Preparation of calibration curves:

Dilutions prepared separately and 20μl of each was   injected into the HPLC system and their chromatograms were recorded. Peak areas were recorded for all the peaks and a standard calibration curve of area under the curve against concentration was plotted.

 

3.7     Selection of analytical concentration:

The standard solution pipetted out into a series of 10 ml vol. flasks. The volume was made up to the mark with the mobile phase and the concentration range, ranging from 4-20μg/ml Naproxen and 10-50μg/ml of Esomeprazole respectively.

 

3.8    Analysis of tablet formulation:

Twenty tablets of average weight of Esomeprazole and Naproxen weighed. The tablets were then crushed to fine powder and powder equivalent to 100 mg of Esomeprazole and 40 mg of Naproxen was weighed and transferred to 100 ml vol. flask. The contents were ultrasonicated for 20 minutes.

 

3.9     Method validation:

The proposed method has been extensively validated in terms of specificity, accuracy, precision, linearity, LOD, LOQ, robustness, and system suitability. The accuracy was expressed in terms of percent recovery of the known amount of the standard drugs added to the known amount of the pharmaceutical dosage forms. The precision (%RSD) was expressed with respect to the repeatability. After validation, the developed methods have been applied to pharmaceutical dosage form.

 

4. RESULT AND DICUSSION:

The present study of simultaneous estimation of Esomeprazole and Naproxen by RP- HPLC method of pharmaceutical dosage form. The linearity of the proposed method was established by least square regression analysis of the calibration curve and the constructed calibration curves were linear and concentration range of 10-50μg/ml for Esomeprazole (r = 0.9999) and 4-20μg/ml Naproxen (r = 0.9999).

 

The robustness was evaluated by analyzing the samples by varying few parameters like wavelength and flow rate. The validation results obtained confirm the suitability of the proposed RP-HPLC method for simple, accurate and precise analysis of Esomeprazole and Naproxen in pharmaceutical preparations.

 

Summary of validation and parameters of Esomeprazole and Naproxen.

Parameters	Esomeprazole	Naproxen
Linear range (µg/ml)	10-50	4-20
Slope	49585	10114
Regression coefficient (r2)	0.9999	0.9999
Limit of Detection (LOD)(µg/ml)	0.0386	0.1171
Limit of Quantification (LOQ) (µg/ml)	0.0216	0.0656
Retention time (min)	3.425	4.352
Tailing factor	1.269	1.283

 

5. SUMMARY AND CONCLUSION:

In this present study, an attempt was made to develop an analytical method for the simultaneous estimation of Esomeprazole and Naproxen in tablet dosage form which is simple and fast. The method gives good resolution between the compounds with a short analysis time. The method was validated to simple, accurate and precise. So the developed method can be used conveniently for analysis of esomeprazole and naproxen in pharmaceutical dosage forms.

 

Therefore it was concluded that the proposed method can be used for routine analysis of Esomeprazole and Naproxen in its tablet dosage form.

 

6. REFERENCES: 

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3.        British Pharmacopoeia, Vol-I, 2005, 168 - 170.

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5.        Gennaro, A.R., Remington., The science and practice of pharmacy, 28^th edition, Luppincott, Williams and Wilkins, Baltimore, Maryland, USA, 2000. pp 534 - 549.

6.        Ghulam A. Shabir, HPLC Method Development and Validation for Pharmaceutical Analysis, 2004, 25-27.

7.        International Conference on Harmonization: ICH Q 2 (R1) Validation of Analytical Procedure, Text and Methodology 1995.

8.        British Pharmacopeia 2007 vol-2.

9.        United States Pharmacopeia 2008 vol-3 (2760)

10.     Chandrakant Sojitra and Sadhana Rajput, International Journal of Pharmacy and Pharmaceutical Sciences, 2012; 4(3).

11.     Akiful Haque, S. Hasan Amrohi, Mahesh Nasare, Prashanth Kumar. K, Pradeep Kumar. T, Nivedita. G and Prakash V Diwan, IOSR Journal of Pharmacy, 2012;4(2).

 

 

 

Received on 16.06.2016         Modified on 02.08.2016

Accepted on 20.08.2016         © AJRC All right reserved