The Malaysian Journal of Analytical Sciences Vol 16 No 3 (2012): 202 – 212

 

 

 

DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC AND A RP-HPLC METHODS FOR MOEXIPRIL HYDROCHLORIDE IN PURE FORM AND PHARMACEUTICAL DOSAGE FORM

 

(Perkembangan dan Validasi Kaedah Spektrofotometri UL dan Kaedah KCPT Fasa Terbalik Bagi Analisis Moexipril Hidroklorida Dalam Keadaan Tulen dan Dalam Dos Farmaseutikal)

 

V. S. Mastiholimath^1*, P. P. Gupte^1*, V. S. Mannur¹, P. M. Dandagi², A. P. Gadad², A. Patil¹, RVSR Bhavyashanthi¹

 

¹Department of Quality Assurance

²Department of Pharmaceutics,

KLE University’s College of Pharmacy,

Belgaum- 590 010, Karnataka, India

 

*Corresponding author: mastiholimath@rediffmail.com or prajaktgupte@gmail.com

 

 

Abstract

A simple and reliable UV spectrophotometric and high-performance liquid chromatography (HPLC) methods were developed and validated for Moexipril hydrochloride in pure form and pharmaceutical dosage form. The RP-HPLC  method was developed on agilant eclipse  C ₁₈ , (150 mm x 4.6 mm, 5 μm) with a mobile phase gradient system of 60% {methanol:acetonitrile (70:30% v/v)} : 40% 20mM ammonium acetate buffer pH 4.5 (v/v) and UV spectrophotometric method was developed in phosphate buffer pH 6.8. The effluent was monitored by SPD-M20A, prominence PDA detector at 210 nm. Calibration curve was linear over the concentration range of 10 –35 μg/ml and 1-9 µg/ml for RP-HPLC and UV with a regression coefficient of 0.999. For RP-HPLC method Inter–day and intra–day precision % RSD values were found to be 1.00078% and 1.49408% respectively. For UV method 0.73386% to 1.44111% for inter day 0.453864 to 1.15542 intra-day precision. Recovery of Moexipril hydrochloride was found to be in the range of 99.8538% to 101.5614% and 100.5297586% to 100.6431587% for UV and RP-HPLC respectively. The limits of detection (LOD) and quantification (LOQ) for HPLC were 0.98969 and 2.99907 μg/ml, respectively. The developed RP-HPLC and UV spectrophotometric method was successfully applied for the quantitative determination of Moexipril hydrochloride in pharmaceutical dosage.

 

Keywords: Moexipril hydrochloride, UV spectrophotometer, RP-HPLC, Pharmaceutical dosage form, Validation

 

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