Asian Journal of Pharmaceutical Analysis

Asma Afroz ¹, Tasnuva Haque ², Md. Mesbah Uddin Talukder ¹, S. M. Ashraful Islam ¹

Affiliations
1 Department of Pharmacy, University of Asia Pacific, Dhanmondi, Dhaka-1209, BD
2 Department of Pharmacy, Stamford University Bangladesh, 51 Siddeswari Road, Dhaka-1217, BD

Abstract

In the present study a simple, precise, accurate and reproducible spectrophotometric method has been developed and validated for the quantification of rosuvastatin calcium and glimepiride in solid dosage form by simultaneous equation method. This method uses the spectrum mode of analysis of Simardzu spectrophotometer (UV 1601 and 1240) and utilizes 241 nm and 231 nm as analytical wavelengths for simultaneous estimation. Both the drugs followed Beer's law in concentration range of 10-22μg/ml. The method was validated in terms of linearity (within 10-22μg/ml), accuracy (% Recovery), precision (inter day and intraday) reproducibility (UV model-1601 and 1240) and robustness. Linearity of the method was with in range and the % recovery was 99.04% for rosuvastatin calcium and 100.94% for glimepiride from the binary mixture. The method was found precise (% RSD<2%). and robust. Therefore the proposed method is suitable and can be adopted for the simultaneous determination of rosuvastatin calcium and glimepiride from combined pharmaceutical dosage form in routine quality control analysis.

Keywords

Rosuvastatin Calcium, Glimepiride, Method Validation, UV, Quantitative Analysis.

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Md. Ahsanul Haque ¹, Mohammad Shahriar ¹, Nazma Parvin ², S. M. Ashraful Islam ¹

Affiliations
1 Department of Pharmacy, University of Asia Pacific, Dhanmondi, Dhaka-1209, BD
2 Department of Pharmacy, Stamford University Bangladesh, 51, Siddeswari Road, Dhaka-1217, BD

Abstract

In the present study, a simple, sensitive and specific liquid chromatography (RP-HPLC) method has been developed and validated for the quantification of ranitidine hydrochloride, domperidone and naproxen in solid dosage form. A shim-pack CLC-ODS column (250 mm X 4.6 mm, 5μ and a mobile phase constituting 0.1 M orthophosphoric acid solution (pH 3.0): methanol (35:65 v/v) were used. The flow rate was 1.0 ml/min and detection was carried by using ultraviolet (UV) detector at a wavelength of 280 nm. The retention times of ranitidine hydrochloride, domperidone and naproxen were 2.702 min, 3.666 min and 9.842 min respectively. The peaks were well separated (resolution 4.55 and 20.2). The calibration curves were linear over the concentration range of 80% to 120% of target concentration (R² > 0.999 for ranitidine and naproxen and 0.998 for domperidone). The method is accurate with 99.5% to 100.04% recovery (% RSD < 1.23). The proposed method was successfully applied for the estimation of ranitidine hydrochloride, domperidone and naproxen and potency was found within limit. Therefore, this method can be used for the analysis of ranitidine hydrochloride, domperidone and naproxen in single or combine dosage form.

Keywords

Ranitidine Hydrochloride, Domperidone, Naproxen, Method Validation, HPLC, Quantitative Analysis.

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