Aspirin

Our life span is genetically programmed and it is possible that a defect in produced proteins encoded by the ‘longevity’ gene is a cause of aging. Progeria which is a rare, fatal genetic condition which affects between one in four million and one in eight million children of both sexes equally and characterized by premature and accelerated aging. The appearance and physiology of these children resembles to elderly people but they typically have life span to their mid teens. It is also known as the Hutchinson-Gilford syndrome, which was initially reported by Johnathan Hutchinson in 1886 and further described by Hastings Gilford in 1904. It is an autosomal recessive disorder, which means an individual has inherited a mutated gene from both parents. It is added to the expanding catalogue of ‘laminopathies’, diseases caused by mutations affecting nuclear lamina proteins known as lamin A (LMNA). Currently, there are about 50 known cases of Progeria in the world and most Progeria patients die at around 13 years of age. Treatment usually includes aspirin which helps prevent the atherothrombotic events, stroke and heart attacks by hindering platelet aggregation. Vitamin supplementation, Fluoride supplements are recommended. A Study of Zoledronic acid, Pravastatin, and Lonafarnib for Patients with Progeria is ongoing, it is under phase II.

A specific, rapid, reliable and precise reversed phase ultra-performance liquid chromatographic method has been developed and validated for the simultaneous estimation of aspirin, clopidogrel and atorvastatin in tablet dosage form. Chromatography was carried out on a 100 × 2.1 mm i.d., 1.7 µm C18 column with gradient flow programming mobile phase The mobile phase is a mixture of two solutions mobile phase A and mobile phase B in the ratio of 30:70. The mobile phase – A, contains buffer and methanol in the ratio of 93:7, the buffer used is 2.76 gms of Sodium phosphate in 100 ml. The mobile phase – B, contains 0.1% orthophosphoric acid and acetonitrile (60:40, v/v), at a flowrate of 0.5 mL/min. The detection was carried out by PDA detector. The retention times were about 0.55, 0.98 and 2.75 min for Aspirin, Clopidogrel and Atorvastatin, respectively. The runtime was 5 mins. The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity and system suitability were found to be under ICH limits. The method was linear in the range of 5-25 µg/mL of Aspirin, 5-25 µg/mL of Clopidogrel and 1-5 µg/mL of Atorvastatin. Limit of detection obtained were 0.02 µg/mL of Aspirin, 0.05 µg/mL of Clopidogrel and 0.07 µg/mL of Atorvastatin.

The objective of the present research work is to develop a isocratic reversed-phase liquid chromatographic (RP-HPLC) method for the determination of Aspirin in pharmaceutical pharmaceutical dosage forms for its related impurities in presence of esomeprazole. The chromatographic separation was achieved on a RP 18 column (100mm×4.6mm, 5 µm). The isocratic LC method employs mixture of buffer methanol and isopropyl alcohol in the ratio of (84:13:3 v/v) solutions as mobile phase. The buffer solution contains 6.8g of Potassium dihydrogen orthophosphate adjusted to pH 2.5 with orthophosphoric acid .The flow rate was 1.5 ml/min and the detection wavelength was 275 nm. In the developed HPLC method, the resolution between Aspirin and its potential impurity salicylic acid was found to be greater than 4.0. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation in presence of esomeprazole. Considerable degradation was found to occur in basic medium and mild degradation observed in acid hydrolysis stress conditions. Degradation product formed during acidic hydrolysis was salicylic acid. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5%. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision and robustness.

The present research work discusses the two new, simple, accurate, precise and reproducible UV spectrophotometric methods have been developed and validated for the simultaneous determination of Prasugrel (PRASU) and Aspirin (ASP) in their combined dosage form.  Method- I is based on simultaneous equation method using two wavelengths, 254 nm (λmax of PRASU) and 276 nm (λmax of ASP). Method - II Q‐absorption ratio method using two wavelengths, 274.7 nm (Isoabsorptive point) and 254 nm (λmax of PRASU). Methanol was the solvent used in all methods. This method obeyed Beer’s law in the concentration range of 5-60 µg /ml for PRASU and 20-140 μg/ml ASP. All methods were validated statistically and recovery studies were carried out. Hence, the methods herein described can be successfully applied in quality control of combined pharmaceutical dosage form.