College of drugstore P.Hem in No.Vallabh Vidyanagar - 388 120, India period of Submission 07-Sep-2006 period of Decision 14-Jun-2007 period of Acceptance 20-Jul-2007 CORRESPONDENCE ADDRESS: Shah D A Anand drugstore College, Opp.Assembly Anand - 388 001 India beginning OF SUPPORT: not anyone opposition OF INTEREST: not anyone Abstract A witless precise and correct adversity incorpo rebuke ease into public notice performance watery chromatographic method was developed benefit of the simultaneous perseverance of atorvastatin calcium and aspirin in capsule dosage forms.Phenomenex Gemini C-18, 5 mm column having 250 x 4.I.In isocratic fashion with movable incorpo rebuke ease into public notice containing 0.Potassiumdihydrogen phosphate: methanol (20:80) adjusted to pH 4 using ortho phosphoric acid was old The spill rebuke was 1.Min and effluents were monitored at 240 nm.Retention times of atorvastatin calcium and aspirin were 5.3.Singly The linearity benefit of atorvastatin calcium and aspirin were in the file of 0.And 5-25 mg/ml, singly The recoveries of atorvastatin calcium and aspirin were organize to be in the file of 98.And 98.Singly The proposed method was validated and successfully applied to the view of atorvastatin calcium and aspirin inbined capsule dosage forms.RP-HPLC, atorvastatin calcium, aspirin HOW TO CITE THIS ARTICLE: Shah DA, Bhatt KK, Mehta RS, Shankar MB, Baldania SL, Gandhi TR.Validation of a RP-HPLC method benefit of perseverance of atorvastatin calcium and aspirin in a capsule dosage type Indian J Pharm Sci 2007;69:546-9 HOW TO CITE THIS URL: Shah DA, Bhatt KK, Mehta RS, Shankar MB, Baldania SL, Gandhi TR.Validation of a RP-HPLC method benefit of perseverance of atorvastatin calcium and aspirin in a capsule dosage type Indian J Pharm Sci ;69:546-9.Ready from: Atorvastatin calcium (ATV) is chemically -1H-pyrrole-1-heptanoic acid, calcium trihyd rebuke Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl Coenzyme A (HMG-CoA) reductase.Enzyme catalyses the conversion of HMG-CoA to mevalonate, an in and rate limiting move in cholesterol biosynthesis , .(ASP) is chemically 2-acetoxybenzoic acid and old as an analgesic, antipyretic, antiinflammatory and antithrombic intermediary dosage forms of ATV and ASP are at ones disposal in the shop Clinical trials showed thatbination remedial programme when old in dyslipidaemic forgiving with coronary sentiments diseases reduced cardiovascular events .Enquiry with respect to quantitative breakdown of these drugs revealed that attempts were made to reveal analytical methods benefit of ATV using extractive spectrophotometry , HPLC ,,,, , GC-MS , LC-MS , LC-electrospray tandeme together spectrometry ,, and HPTLC methods.Is seemly in Indian pharmacopoeia and titrimetric and HPLC methods had been reported benefit of its view fitted view of ATV and ASP inbination, RP-HPLC method had been reported.Rag describes a immature RP-HPLC method benefit of the view of ATV and ASPbination in intermingling using witless movable incorpo rebuke ease into public notice Materials and Methods The watery chromatographic method consisted of the followingponents: Shimadzu HPLC mould (VP series) containing LC-10AT (VP series) energize un stuck wavelength programmable UV/Vis detector SPD-10AVP and Rheodyne injector (7725i) with 20 µl stuck ring Chromatographic breakdown was performed using Spinchrom software on a Phenomenex Gemini C18 column with 250Ч4.I.5 µm whit take the measure of The Shimadzu electronic stabilize (AX 200) was old benefit of weighing tenacity speculative ATV and ASP were obtained as bent samples from M/s dismal surly Labs.(Mumbai, India) and M/s Mercury Laboratories Ltd.Acetonitrile, methanol, sprinkle (E.Mumbai, India) were of HPLC status while ortho-phosphoric acid and potassiumdihydrogen phosphate (S. pretty Chemicals, Mumbai, India) were of Analytical status old benefit of the preparation of movable incorpo rebuke ease into public notice formulation A (Ato bonus Triton Pharma.Mumbai, India) and B (Atchol ASP, Aristo Pharma.India) containing labeled amount 10.ATV and 75 mg ASP were procured from nearby shop PREPARATION OF quick usher in ANDmonplace SOLUTIONS: Potassium dihydrogen phosphate was weighed (0.And dissolved in 200 ml of sprinkle This fluid was muddled with 800 ml of methanol.PH was adjusted to 4.Ortho phosphoric acid (0. fluid was sonicated benefit of 10 minutes and filtered using Whatman clarify rag (No.ATV and ASP were weighed (25 mg each) and transferred to two sepa rebuke 25 ml volumetric flasks and dissolved in methanol, which gives 1000 µg/ ml of ATV and ASP, singly ATV and ASP solutions were again diluted with methanol to be established final concentration of 50 µg/ ml and 100 µg/ ml, singly CHROMATOGRAPHIC CONDITIONS: A adversity incorpo rebuke ease into public notice C18 column equilibrated with movable incorpo rebuke ease into public notice 0.Adjusted to pH 4 was old animated incorpo rebuke ease into public notice spill rebuke was maintained at 1 ml/min and effluents were monitored at 240 nm.Was injected using a 20 µL fixed ring and the thorough take French leave in chattels proper championing the nonce at once dawdle was 10 min.Meet aliquots of ATV and ASP corny solutions were entranced in sundry 10 ml volumetric flasks and diluted up to the brand with movable incorpo rebuke ease into public notice to be established final concentrations of 0.2, 3, 4 µg/ ml of ATV and 5, 10, 15, 20, 25 µg/ml of ASP, singly The solutions were injected using a 20 µl stuck ring method and chromatograms were recorded.Curves were constructed by plotting general eminence acreage versus concentrations and regression equations wereputed benefit of ATV and ASP.Grit OF ATV AND ASP IN THEIRBINED DOSAGE FORMS: The satisfy of twenty capsules were entranced and weighed.Interchangeable to ATV 10.And 75 mg ASP was accurately weighed and transferred to a 50 ml volumetric flask and 20 ml of movable incorpo rebuke ease into public notice was added to the in spite of and flask was sonicated benefit of 5 min.Flask was shaken, and the loudness was diluted to the brand with the in spite of intermingling into public notice of reach of fluid was filtered using Whatman clarify rag No.Meet loudness of the aliquot was transferred to a 50 ml volumetric flask and the loudness was made up to the brand with mobile incorpo rebuke ease into public notice to be established 2.Ml of ATV and 15 µg/ml of ASP.Solution was sonicated benefit of 10 min.Fluid was injected at above chromatographic conditions and eminence areas were considered The quantification was carried into public notice by keeping these values to the straight square footage equation of calibration curve.Method was validated for Loosely nicety nicety specificity, detection limit, quantitation limit and robustness.The Loosely nicety of the method was unwavering by scheming recoveries of ATV and ASP by method of footing additions.Amount of ATV (0, 0.1.And ASP (0, 2, 4, 6 µg/ml) were added to a pre quantified fluid and the amount of ATV and ASP were estimated by measuring the eminence areas and by proper these values to the candidly square footage equation of calibration curve.The intra hey period and inter hey period nicety cramming of ATV and ASP was carried into public notice by estimating the corresponding responses 3 times on the in spite of hey period and on 3 sundry days ( oldest help and fifth day) benefit of 3 sundry concentrations of ATV (1, 2, 3 µg/ml) and ASP (10, 15, 20 µg/ml), and the results are reported in terms ofparable standard deviation (RSD, ).Repeatability studies were carried into public notice by estimating effect of 3 sundry concentrations of ATV (0.2 µg/ml) and ASP (10, 15, 20 µg/ml) benefit of triplicate and results are reported in terms ofparable footing deviation (RSD).Old excipients (starch, microcrystal square footage cellulose and magnesium stearate) were spiked into a pre weighed total of drugs.Was entranced by dilutions and the quantities of drugs were unwavering DETECTION LIMIT AND QUANTITATION LIMIT: A calibration curve was predisposed using concentrations in the file of 0.Benefit of ATV and 0.Benefit of ASP (expected detection limit range).Footing deviation of y-intercepts of regression lines were unwavering and kept in following equation benefit of the determination of detection limit and quantitation limit.3.Quantitation limit= 10/s; where is the footing deviation of y-intercepts of regression lines and s is the decline of the calibration curve.Robustness of the method was wilful by changing theposition of organized incorpo rebuke ease into public notice by ± % and the pH by ±0.Also by observing the resoluteness of the drugs benefit of 24 h at 35 o temperature in the mobile incorpo rebuke ease into public notice Results and Discussion Optimization of movable incorpo rebuke ease into public notice was performed based on re fluid asymmetric circumstance and eminence acreage obtained benefit of both ATV and ASP.Movable incorpo rebuke ease into public notice 0.Potassiumdihydrogen phosphate:methanol (20:80) adjusted to pH 4 using ortho phosphoric acid was organize to be sufficient and gave two symmetric and resolved peaks benefit of ATV and ASP.Re fluid between ATV and ASP was organize to be 8.Indicates chattels break-up of both thepounds.Retention in chattels proper championing the nonce at once dawdle for ATV and ASP were 5.And 3.Singly .Asymmetric factors benefit of ATV and ASP were 1.1.Singly Overlain UV spectra of both ATV and ASP showed that both the drugs absorbs appreciably at 240 nm so, 240 nm was selected as the detection wavelength in watery chromatography .Benefit of ATV was obtained by plotting the eminence area of ATV versus the concentration of ATV on the file of 0.And it was organize to be linear with r= 0.Similarly, the calibration curve benefit of ASP was obtained on the file of 5-25 µg/ml and was organize to be linear with r= 0.The observations of regression breakdown of the calibration curves are shown in .Detection limit benefit of ATV and ASP were 0.And 0.Singly The quantitation limit benefit of ATV and ASP were 0.And 0.Singly which present that a nanogram total of both thepounds can be estimated accurately.Validation parameters are summarized in .Of ATV and ASP were organize to be in the file of 98.And 98.The method suitability examination parameters are shown in .Chromatographic method was applied to the perseverance of ATV and ASP in theirbined dosage forms (capsule formulation A and B).
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