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ABSTRACT:
Accurate and precise high performance liquid chromatography (HPLC) method was developed for the determination of Paracetamol (Par) and Codeine phosphate (Cod) in pharmaceutical formulations. The chromatographic separation was achieved with acetonitrile: phosphoric acid (pH = 2.8) in ratio of 35:65 (v/v) as mobile phase on a Shim-pack clc-C8 column (25 cm x 4.6 mm i.d., 5 pm) with UV detection at 212 nm, pump flow rate 1.0 mL/min and sample injection volume 20 pL. The analysis time was < 8 min. The method was validated with respect to linearity, precision, accuracy, selectivity and specificity. The calibration curves showed good linearity over the concentration range of (3 - 600) pg/mL and (1 - 800) pg/mL for (Par) and (Cod) respectively in presence of methyl paraben (MP) as internal standard. The proposed method was successfully applied to analysis individual or mixture of (Par) and (Cod) in Syrian trademark drugs. All studied samples showed that the drug levels were conformed to united state pharmacopeia (USP) legislation. Finally, the described chromatographic procedure here is accurate, precise, selective and suitable for routine quality control analysis and stability tests.
KEYWORDS: HPLC, Paracetamol, Codeine phosphate.
INTRODUCTION:
Paracetamol:
N-(4-Hydroxyphenyl) acetamide or Paracetamol (Par) is a white or almost white crystalline powder. Sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride1, fig. 1,a.
(Par) is a p-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. (Par) is thought to produce analgesia through a central inhibition of prostaglandin synthesis2.
Codeine phosphate:
7,8 -Didehydro -4,5a-epoxy-3 -methoxy-17-methylmorphinan-6a-ol phosphate hemihydrate or Codeine phosphate (Cod) is a White or almost white, crystalline powder or small, colorless crystals.
Freely soluble in water, slightly soluble or very slightly soluble in ethanol (96 percent)1, fig. 1,b.
(Cod) belongs to a group of medicines called analgesics, which are used to block pain. It is an opioid analgesic, and it acts by blocking pain and emotional response to pain2. (Par) and (Cod) have been determined by various instrumental methods such as spectrophotometry3,4,5, high performance liquid chromatography (HPLC)6,7,8, micellar liquid chromatography9, electrochemical analysis10,11,12,13,14.
MATERIALS AND METHODS:
Apparatus:
HPLC analysis was performed on an YL 9100 HPLC system equipped with binary pump YL9111, vacuum degasser series YL9101, YL9130 column compartment and YL9120, UV/Vis. Detector...