title: RP-HPLC method development and validation for simultaneous estimation of atorvastatin calcium and pioglitazone hydrochloride in pharmaceutical dosage form.
abstract: A simple, selective, rapid, precise and economical reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for simultaneous estimation of atorvastatin calcium (ATV) and pioglitazone hydrochloride (PIO) from pharmaceutical formulation. The method is carried out on a C8 (25 cm × 4.6 mm i.d., 5 μm) column with a mobile phase consisting of acetonitrile (ACN):water (pH adjusted to 6.2 using o-phosphoric acid) in the ratio of 45:55 (v/v). The retention time of ATV and PIO is 4.1 and 8.1 min, respectively, with the flow rate of 1 mL/min with diode array detector detection at 232 nm. The linear regression analysis data from the linearity plot showed good linear relationship with a correlation coefficient (R(2)) value for ATV and PIO of 0.9998 and 0.9997 in the concentration range of 10-80 µg mL(-1), respectively. The relative standard deviation for intraday precision has been found to be <2.0%. The method is validated according to the ICH guidelines. The developed method is validated in terms of specificity, selectivity, accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method can be used for simultaneous estimation of these drugs in marketed dosage forms.
authors.affiliation: Division of Pharmaceutical Analysis and Quality Assurance, Center for Pharmaceutical Research (CPR), Raghavendra Institute of Pharmaceutical Education and Research (RIPER), K.R. Palli Cross, Chiyyedu (Post), Anantapur, AP 515721, India.
authors.forename: Ramalingam
authors.initials: R
authors.lastname: Peraman
authors.affiliation: Division of Pharmaceutical Analysis and Quality Assurance, Center for Pharmaceutical Research (CPR), Raghavendra Institute of Pharmaceutical Education and Research (RIPER), K.R. Palli Cross, Chiyyedu (Post), Anantapur, AP 515721, India mallikarjuna.sasikala753@gmail.com rammpharm@rediffmail.com.
authors.forename: Sasikala
authors.initials: S
authors.lastname: Mallikarjuna
authors.affiliation: Division of Pharmaceutical Analysis and Quality Assurance, Center for Pharmaceutical Research (CPR), Raghavendra Institute of Pharmaceutical Education and Research (RIPER), K.R. Palli Cross, Chiyyedu (Post), Anantapur, AP 515721, India.
authors.forename: Pravalika
authors.initials: P
authors.lastname: Ammineni
authors.affiliation: Division of Pharmaceutical Analysis and Quality Assurance, Center for Pharmaceutical Research (CPR), Raghavendra Institute of Pharmaceutical Education and Research (RIPER), K.R. Palli Cross, Chiyyedu (Post), Anantapur, AP 515721, India.
authors.forename: Vinod kumar
authors.initials: Vk
authors.lastname: Kondreddy
mesh_terms: D000069059:Atorvastatin; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004304:Dosage Forms; D004338:Drug Combinations; D006538:Heptanoic Acids / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D057230:Limit of Detection; D010756:Phosphoric Acids / Q000737:chemistry; D000077205:Pioglitazone; D011758:Pyrroles / Q000032:analysis*; D015203:Reproducibility of Results; D045162:Thiazolidinediones / Q000032:analysis*
chemical_list: D004304:Dosage Forms; D004338:Drug Combinations; D006538:Heptanoic Acids; D010756:Phosphoric Acids; D011758:Pyrroles; D045162:Thiazolidinediones; D000069059:Atorvastatin; C030242:phosphoric acid; D000077205:Pioglitazone